Fresh Farms LLC

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WARNING LETTER

April 19, 2022

Dear Mr. Yenovkian:

The U.S. Food and Drug Administration inspected your drug manufacturing facility, Fresh Farms LLC, FEI 3016866993, at 3360 North Las Vegas Blvd Unit E024, Las Vegas, NV 89115, from November 8 to November 11, 2021.

This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

We reviewed your November 23, 2021 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Your response is inadequate because you failed to provide supportive documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP. In addition, your response claims that you comply with various CGMP requirements. However, this contradicts the statements you made during the inspection.

During our inspection, our investigators observed specific violations including, but not limited to, the following.

1. Failure to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)).

Your firm manufactures over the counter (OTC) Hand Sanitizer¹ drug products including (b)(4) Hand Sanitizer. Your firm’s quality systems are inadequate. Your firm failed to establish an adequate quality unit with responsibilities to ensure adequate oversight for the manufacture of your OTC drug products. For example, you failed to ensure that the responsibilities of the quality unit are in writing and fully followed, that your products specifications are established and approved, and that the final review of each batch and its related information are adequately documented and completed before release and distribution.

An adequate quality unit overseeing all manufacturing operations is necessary to consistently ensure drug quality. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.

2. Your firm failed to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined, as appropriate, and released for use by the quality control unit (21 CFR 211.84(a))

You failed to sample, test, and examine components used in the manufacture of your OTC drugs including ethanol which is used as an active pharmaceutical ingredient (API) in the manufacture of (b)(4) Hand Sanitizer drug product. During the inspection, you stated that you did not test your incoming raw materials prior to use. You told our investigators that your customer, “(b)(4),” was responsible for sourcing materials, including ethanol. However, this does not absolve you of your responsibility as the manufacturer to sample, test, and examine drug components prior to use to assure adequate quality, including testing for the presence of methanol in ethanol, before use in production.

The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19) to help you meet the CGMP requirements when manufacturing drugs containing ethanol at https://www.fda.gov/media/145262/download.

3. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).

You failed to perform release testing for batches of (b)(4) Hand Sanitizer labeled as containing ethanol. During the inspection, you stated that no release testing was performed on your drug products. Drug products must be tested for identity, strength, quality, and purity prior to release. Testing is essential to ensure that the drug products you manufacture conform to all pre-determined quality attributes that are appropriate for their intended use, including microbiological specifications.

4. Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).

You lacked executed batch records for batches of (b)(4) Hand Sanitizer drug product you manufactured. During the inspection, you stated that no batch records were prepared. You also stated that your employees knew the formulation and final concentration of the hand sanitizer and therefore, production was to be performed in the same manner every time to yield finished product of the desired concentration. Without executed batch records, you cannot verify that each significant step of your drug production process is completed as intended to assure uniformity from batch to batch, including but not limited to weights and measures of components, using correct equipment, adhering to all critical processing parameters, and statement of yields. Additionally, you are unable to determine if errors have occurred and whether such errors may impact product quality or patient safety, and traceability back to the individual batches.

Drug Production Ceased

We acknowledge your commitment to cease production of drugs at this facility. If you plan to resume manufacturing drugs, notify this office before resuming your operations.

Responsibilities as a Contractor

Drugs must be manufactured in conformance with CGMP. The FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. The FDA regards contractors as extensions of the manufacturer.

You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act for safety, identity, strength, quality, and purity. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.

CGMP Consultant Recommended

If your firm intends to resume manufacturing drugs for the U.S. market, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility, in connection with your product(s). You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.

Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.

Failure to address violations may also cause the FDA to withhold issuance of Export Certificates. The FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Please send your electronic reply to ORAPHARM4_Responses@FDA.HHS.GOV or mail your reply to:

CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
U.S. Food & Drug Administration
19701 Fairchild Road
Irvine, California 92612-2506

Please identify your responses with the unique identifier: CMS 623723

If you have questions regarding the contents of this letter, please contact Andrew Haack, Compliance Officer by telephone at 206-340-8212 or email at Andrew.Haack@fda.hhs.gov.

Sincerely,
/S/

CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV

CC:
(b)(6), (b)(4)

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1 Due to an increased demand for alcohol-based hand sanitizers during the COVID-19 pandemic, the FDA published the Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) on March 19, 2020, and subsequently updated the guidance several times. The guidance was withdrawn effective December 31, 2021 (86 Fed Reg at 56960). This guidance communicated the agency’s temporary policy that we did not intend to take action against firms for CGMP violations under section 501(a)(2)(B) of the FD&C Act if such firms prepared alcohol-based hand sanitizers for consumer use (or for use as a health care personnel hand rub) during the public health emergency, provided certain circumstances described in the guidance are present. These circumstances included preparation of hand sanitizer products using only the ingredients and formulas set forth in the guidance. Because (b)(4) hand sanitizer product is not consistent with the formulations described in these guidances, it does not fall within any temporary agency policy not to take action against firms manufacturing hand sanitizer products for violations of section 505 of the FD&C Act.