PReye, LLC

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August 18, 2026

WARNING LETTER
Reference number: 320-26-118

To Dr. Melinda C. O’Rourke:

This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of your products and facilities. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory action without further notice including, without limitation, seizure and injunction.

FDA Inspection

Violations were observed and documented during an inspection of your drug manufacturing facility, PReye, LLC, FDA Establishment Identifier (FEI) 3031057987, at 4855 Ward Road, Wheat Ridge, from March 17 to 19, 2026. This inspection was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.

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).

In addition, violations were identified and documented during the review of your website https://essencelaser.com/vitaminsee/ in June 2026. Based on our review, “PReye Vitamin SEE” is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

We reviewed your March 22, 2026, response to our Form FDA 483 in detail.

Violations of the Federal Food, Drug, and Cosmetic Act

The following are violations identified during our inspection and review. As a reminder, this is not an all-inclusive list of violations at your facility.

CGMP Violations

1. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas. Your firm also failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.42(c)(10) and 21 CFR 211.63).

Your firm was registered as a drug repacker and produced drug products solely for distribution through the co-located med spa, Essence Laser and Wellness, which you own. Your repackaging operations consisted of a small flow hood on a desk in your office. These operations were performed in a non-certified, non-qualified flow hood within an unclassified office space that lacked a high-efficiency particulate air (HEPA) filtration system.

You obtained bulk liquid drug and manually filled multiple (b)(4) drug products. The drug product was labeled with directions to use “(b)(4)”. Your (b)(4) products were filled under unsuitable aseptic processing conditions, in that they lacked appropriate facilities, equipment, and process controls to protect the drug product from microbiological contamination.

Your manufacturing facility, equipment, and process must be designed, and operations must be executed, to prevent contamination risks to sterile drug products (e.g., (b)(4) drug products).

2. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

Your firm's quality systems are inadequate. Your firm lacked a quality unit (QU) function and associated written procedures defining QU responsibilities and controls. You failed to establish basic procedures including, but not limited to, complaint review, supplier qualification, release testing, change management, cleaning, disinfection, and deviation handling. In addition, your ophthalmic drug products lack traceability because you did not issue batch numbers for all sterile drug products manufactured since 2024.

An adequate QU overseeing all manufacturing operations is necessary to consistently ensure drug quality. You failed to implement fundamental procedures and practices to ensure the safety, identity, strength, quality, and purity of your drug products. 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.

Unapproved New Drug Violations

Based on a review of your website, “PReye Vitamin SEE” is a drug under 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/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of the product as a drug include, but may not be limited to, the following:

PReye Vitamin SEE
On the webpage https://essencelaser.com/vitaminsee/:

• “Antioxidant Vitamins provide protection against the damaging effects of UV light from sun exposure. . . . In the eye, UV light ages all the structures. Ocular surface damage, cataracts and macular degeneration are all possible effects from UV exposure and can ultimately lead to decreased vision, and blindness.”
• “Both Ascorbic Acid and Acetylcysteine have been used independently to treat pathology in the eye, including corneal alkali burns and filamentary keratitis in severe dry eye. But, never have they been combined as a vitamin supplement eyedrop to prevent eye disease related to UV exposure, including cataracts and macular degeneration.”

“PReye Vitamin SEE” is a "new drug" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in the labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Additional Guidance on Drug Listing

We note that your firm’s drug listing for “PReye Vitamin SEE” has not been updated or certified as required and therefore has been inactivated by FDA. Please update the listing information for this drug to reflect its current status. If you no longer manufacture and distribute this drug, it must be discontinued by adding an end marketing date.

Additional Guidance on Aseptic Processing

See FDA’s guidance document Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice to help you understand CGMP requirements for sterile drugs produced by aseptic processing at https://www.fda.gov/media/71026/download.

Container Closure for (b)(4) Formulations

When contaminated, (b)(4) drug products pose a significant risk of harm because (b)(4) administration bypasses some of the body’s natural defenses. Irreversible damage, including (b)(4) can occur, and in some cases, may progress to life-threatening systemic infection. The risk is exacerbated when (b)(4) drug products lack a (b)(4) and lack data to demonstrate that the container-closure system can prevent microbiological ingress, contamination, and proliferation.

Drug Production Ceased

On March 22, 2026, you communicated your commitment to cease manufacturing and distribution of PReye Vitamin SEE for the U.S. market for the future. We acknowledge your commitment to cease production of PReye Vitamin SEE drugs at this facility.

If you plan to resume any drug manufacturing operations, including repackaging, notify this office before commencing operations. If you resume CGMP activities, you are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In addition, based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of all corrective action and preventive action, before you pursue resolution of your firm’s compliance status with FDA.

In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all corrective action and preventive action (CAPA).

Drug Recall

On May 11, 2026, FDA held a teleconference with you recommending you consider removing any batches of PReye Vitamin SEE currently in distribution from the U.S. market.

On May 18, 2026, you issued a voluntary recall of PReye Vitamin SEE due to lack of sterility testing.

Conclusion

You are responsible for implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.

Unresolved violations may prevent other Federal agencies from awarding contracts. Failure to address violations may also cause FDA to withhold issuance of Export Certificates. 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.

Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with FEI 3031057987 and ATTN: Compliance Officer Nancy Scheraga in the letter or in the subject line of the email.

If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.

FDA posts warning letters on www.FDA.gov.

Sincerely,
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

/S/

Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
U.S. Center for Drug Evaluation and Research