[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-bpi-labs-llc-699533-03202025":3,"fda-latest-sync-dates":30},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":8,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":18,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":28,"updated_at":29},992,"bpi-labs-llc-699533-03202025","Warning Letter","BPI Labs, LLC",null,"Center for Drug Evaluation and Research (CDER)","Unapproved New Drugs\u002FMisbranded","2025-03-25","2025-03-20","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fbpi-labs-llc-699533-03202025","699533","Drugs","Via Email","Chandra Kasireddy","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">Via Email\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Drugs                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Chandra Kasireddy\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Chief Operating Officer\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>BPI Labs, LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">12393 S Belcher Road Ste 450\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Largo\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">FL\u003C\u002Fspan> \u003Cspan class=\"postal-code\">33773\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:chandrak@belcherpharma.com \"> chandrak@belcherpharma.com \u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Drug Evaluation and Research (CDER)\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>March 20, 2025\u003C\u002Fp>\u003Cp class=\"text-align-center\">RE: 699533\u003C\u002Fp>\u003Cp>Dear Mr. Kasireddy:\u003C\u002Fp>\u003Cp>This letter concerns your firm’s, BPI Labs, LLC’s (BPI’s), distribution of its Epinephrine Chloride Nasal Solution 1 mg\u002FmL, 10 mL. The U.S. Food and Drug Administration (FDA) reviewed your product, including product labeling.\u003C\u002Fp>\u003Cp>Your Epinephrine Chloride Nasal Solution product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), 331(d). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).\u003C\u002Fp>\u003Cp>This product is also misbranded under section 502(i) of the FD&C Act, 21 U.S.C. 352(i). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.\u003C\u002Fp>\u003Cp>\u003Cstrong>Unapproved New Drug Violations\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Epinephrine Chloride Nasal Solution is a drug within the meaning of section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1) because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and\u002For intended to affect the structure or any function of the body of man or other animals. Specifically, this product is intended for use as a nasal decongestant\u002Fvasoconstrictor. Examples of claims observed on BPI’s Epinephrine Chloride Nasal Solution labeling, including the product label, that provide evidence of its intended use (as defined in 21 C.F.R. 201.128) include, but may not be limited to, the following:\u003C\u002Fp>\u003Cul>\u003Cli>“Vasoconstrictor for Topical Application”\u003C\u002Fli>\u003Cli>“For use as a nasal decongestant”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>In general, a drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an application approved by FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a).\u003C\u002Fp>\u003Cp>FDA is not aware of any adequate and well-controlled clinical trials in published literature that support a determination that Epinephrine Chloride Nasal Solution is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling. Moreover, there is no evident basis under the FD&C Act under which the product would be legally marketed without an approved application. Further, no FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this product. Accordingly, this product is an unapproved new drug marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). The introduction or delivery for introduction of unapproved new drug products into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).\u003C\u002Fp>\u003Cp>\u003Cstrong>Misbranding Violations\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Section 502(i)(1) of the FD&C Act, 21 U.S.C. 352(i)(1), provides that a drug is misbranded if “its container is so made, formed, or filled as to be misleading . . .” BPI’s unapproved Epinephrine Chloride Nasal Solution product is labeled for use as a topical nasal decongestant, to be “[a]ppl[ied] locally as drops or spray, or with a sterile swab, as required.” Notwithstanding its intended use as a topical drug, the container closure system for BPI’s unapproved epinephrine nasal solution appears identical to that used for BPI’s FDA-approved epinephrine injection product, which is a small glass vial with a flip-off cap that protects a needle penetrable seal. This type of glass vial is a container closure that is customarily used by drug manufacturers to package small volumes (e.g., 10 or 20 mL) of sterile injectable drugs intended for parenteral administration (including intravenous administration). The Epinephrine Chloride Nasal Solution glass vial and its similarity to the glass vials for your FDA-approved Epinephrine Injection may mislead users into believing the product is intended for injection and thereby, increase the risk of erroneous administration. FDA has received reports of confusion between your firm’s unapproved Epinephrine Chloride Nasal Solution and FDA-approved Epinephrine Injection resulting in the erroneous preparation of your unapproved nasal product for parenteral administration.\u003Cem>\u003Cstrong>\u003Csup>1\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> As such, your unapproved Epinephrine Chloride Nasal Solution product, packaged in a container that appears identical to containers ordinarily used to package sterile injectable drugs, is a misbranded drug under section 502(i)(1) of the FD&C Act, 21 U.S.C. 352(i)(1).\u003C\u002Fp>\u003Cp>The introduction or delivery for introduction into interstate commerce of a misbranded drug violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\u003C\u002Fp>\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.\u003C\u002Fp>\u003Cp>This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.\u003C\u002Fp>\u003Cp>Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you no longer manufacture or market the above-mentioned product, your response should indicate this, including the reasons that, and the date on which, you ceased production. Also, please indicate your progress in updating the drug listing eDRLS files in accordance with 21 C.F.R. 207.57(b). If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot address any violations within fifteen working days, state the reason for the delay and the time within which you will do so.\u003C\u002Fp>\u003Cp>Your response should be sent to U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “699533” in the subject line of the email.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003Cbr>Tina Smith, M.S.\u003Cbr>Captain, U.S. Public Health Service\u003Cbr>Director\u003Cbr>Office of Unapproved Drugs & Labeling Compliance\u003Cbr>Office of Compliance\u003Cbr>Center for Drug Evaluation and Research\u003Cbr>U.S. Food and Drug Administration\u003C\u002Fp>\u003Cp>________________\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> On January 16, 2025, FDA published a news release titled “FDA warns health care professionals not to use epinephrine nasal solutions from BPI Labs and Endo USA,” see https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-safety-and-availability\u002Ffda-warns-health-care-professionals-not-use-epinephrine-nasal-solutions-bpi-labs-and-endo-usa. This news release warns health care professionals not to use unapproved epinephrine nasal solutions due to risk of administration error.\u003C\u002Fp>\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVia Email\n\nProduct:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nChandra Kasireddy\n\nRecipient Title\n\nChief Operating Officer\n\nBPI Labs, LLC\n\n12393 S Belcher Road Ste 450\n\nLargo, FL 33773\n\nUnited States\n\nchandrak@belcherpharma.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nWARNING LETTER\nMarch 20, 2025\nRE: 699533\nDear Mr. Kasireddy:\nThis letter concerns your firm’s, BPI Labs, LLC’s (BPI’s), distribution of its Epinephrine Chloride Nasal Solution 1 mg\u002FmL, 10 mL. The U.S. Food and Drug Administration (FDA) reviewed your product, including product labeling.\nYour Epinephrine Chloride Nasal Solution product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), 331(d). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).\nThis product is also misbranded under section 502(i) of the FD&C Act, 21 U.S.C. 352(i). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.\nUnapproved New Drug Violations\nEpinephrine Chloride Nasal Solution is a drug within the meaning of section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1) because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and\u002For intended to affect the structure or any function of the body of man or other animals. Specifically, this product is intended for use as a nasal decongestant\u002Fvasoconstrictor. Examples of claims observed on BPI’s Epinephrine Chloride Nasal Solution labeling, including the product label, that provide evidence of its intended use (as defined in 21 C.F.R. 201.128) include, but may not be limited to, the following:\n“Vasoconstrictor for Topical Application”\n“For use as a nasal decongestant”\nIn general, a drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an application approved by FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a).\nFDA is not aware of any adequate and well-controlled clinical trials in published literature that support a determination that Epinephrine Chloride Nasal Solution is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling. Moreover, there is no evident basis under the FD&C Act under which the product would be legally marketed without an approved application. Further, no FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this product. Accordingly, this product is an unapproved new drug marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). The introduction or delivery for introduction of unapproved new drug products into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).\nMisbranding Violations\nSection 502(i)(1) of the FD&C Act, 21 U.S.C. 352(i)(1), provides that a drug is misbranded if “its container is so made, formed, or filled as to be misleading . . .” BPI’s unapproved Epinephrine Chloride Nasal Solution product is labeled for use as a topical nasal decongestant, to be “[a]ppl[ied] locally as drops or spray, or with a sterile swab, as required.” Notwithstanding its intended use as a topical drug, the container closure system for BPI’s unapproved epinephrine nasal solution appears identical to that used for BPI’s FDA-approved epinephrine injection product, which is a small glass vial with a flip-off cap that protects a needle penetrable seal. This type of glass vial is a container closure that is customarily used by drug manufacturers to package small volumes (e.g., 10 or 20 mL) of sterile injectable drugs intended for parenteral administration (including intravenous administration). The Epinephrine Chloride Nasal Solution glass vial and its similarity to the glass vials for your FDA-approved Epinephrine Injection may mislead users into believing the product is intended for injection and thereby, increase the risk of erroneous administration. FDA has received reports of confusion between your firm’s unapproved Epinephrine Chloride Nasal Solution and FDA-approved Epinephrine Injection resulting in the erroneous preparation of your unapproved nasal product for parenteral administration.1 As such, your unapproved Epinephrine Chloride Nasal Solution product, packaged in a container that appears identical to containers ordinarily used to package sterile injectable drugs, is a misbranded drug under section 502(i)(1) of the FD&C Act, 21 U.S.C. 352(i)(1).\nThe introduction or delivery for introduction into interstate commerce of a misbranded drug violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\nConclusion\nThis letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.\nThis letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.\nPlease notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you no longer manufacture or market the above-mentioned product, your response should indicate this, including the reasons that, and the date on which, you ceased production. Also, please indicate your progress in updating the drug listing eDRLS files in accordance with 21 C.F.R. 207.57(b). If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot address any violations within fifteen working days, state the reason for the delay and the time within which you will do so.\nYour response should be sent to U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “699533” in the subject line of the email.\nSincerely,\n\u002FS\u002F\nTina Smith, M.S.\nCaptain, U.S. Public Health Service\nDirector\nOffice of Unapproved Drugs & Labeling Compliance\nOffice of Compliance\nCenter for Drug Evaluation and Research\nU.S. Food and Drug Administration\n________________\n1 On January 16, 2025, FDA published a news release titled “FDA warns health care professionals not to use epinephrine nasal solutions from BPI Labs and Endo USA,” see https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-safety-and-availability\u002Ffda-warns-health-care-professionals-not-use-epinephrine-nasal-solutions-bpi-labs-and-endo-usa. This news release warns health care professionals not to use unapproved epinephrine nasal solutions due to risk of administration error.","2026-08-19T16:54:51.026+00:00",[23,24,25,9,26,27,27,27],"\u003Ctime datetime=\"2025-03-25T04:00:00Z\">03\u002F25\u002F2025\u003C\u002Ftime>\n","\u003Ctime datetime=\"2025-03-20T04:00:00Z\">03\u002F20\u002F2025\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fbpi-labs-llc-699533-03202025\">BPI Labs, LLC\u003C\u002Fa>","Unapproved New Drugs\u002FMisbranded \u003Cbr \u002F>\r\n","","2026-08-18T06:42:28.676509+00:00","2026-08-20T02:24:56.037289+00:00",{"510k":31,"classification":32,"enforcement":33,"event":34,"pma":35,"warning_letter":36},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]