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Warning Letter 320-26-36

January 7, 2026

Dear Mr. Pressman:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Winder Laboratories, LLC, FEI 3008694072, at 716 Patrick Industrial Lane, Winder, Georgia, from July 14 to August 5, 2025.

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 August 26, 2025, response to our Form FDA 483 in detail, and we acknowledge receipt of your subsequent correspondence

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

1. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality of purity of the drug product beyond the official or other established requirements and you failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(a) and (b))).

Failure to Clean Equipment

You have not demonstrated that your cleaning practices are adequate to remove contaminants from the nondedicated equipment used to manufacture your prescription drug products, including (b)(4) tablets and (b)(4) tablets. Multiple pieces of manufacturing equipment, including the (b)(4) and the Tablet Press, were observed to have drug product residue and oxidized metal surfaces, which were documented as being clean and were released by your quality unit. Additionally, the dedicated (b)(4) equipment showed visible product residue, oxidized metal, and foreign material, despite being cleaned and released by your quality unit.

Similar equipment cleaning deficiencies were cited during your previous FDA inspections, indicating that your cleaning procedures are insufficient to prevent contamination that could alter the safety, identity, strength, quality, or purity of your drug products.

Additionally, your firm's voluntary recall of (b)(4)mg (b)(4) tablets due to (b)(4) mg tablets being found inside the bottle could be associated to inadequate line clearance of equipment prior to use.

In your response, you state that you have implemented a new procedure requiring the use of a flashlight to detect residues or surface abnormalities not visible to the naked eye, and you provided training on the revised procedures.

Your response is inadequate because you do not provide evidence that your cleaning methods are appropriate and effective, nor do you assess the impact of your inadequate cleaning processes on drug product that is currently on the market and within expiry.

Failure to Maintain Equipment

You failed to adequately maintain your equipment. For example, the metal detection equipment MFG-1276 was found to be nonfunctioning during the inspection. Your preventive maintenance procedures were also inadequate, focusing only on the metal detector’s physical appearance rather than its operational functionality.

Additionally, your executed metal detector qualification protocol did not include the qualification of the metal detector MFG-1276.

These equipment maintenance failures compromise your ability to detect and prevent contamination. Notably, a metal screw was found in a sealed bottle of (b)(4)mg, lot (b)(4).

In your response, you stated that you halted all packaging activities and did not resume packaging operations until the metal detectors had been repaired, and preventive maintenance had been performed.

Your response is inadequate because you did not commit to completing the equipment qualification for the metal detector or describe how you will periodically requalify it. Additionally, you did not commit to conducting a retrospective risk assessment for batches that were processed while the metal detector was not functioning properly.

In response to this letter, provide the following:

• A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment whether cross-contaminated products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices, and encompass each piece of manufacturing equipment used to manufacture more than one product.
• A corrective actions and preventive actions (CAPA) plan, based on the retrospective assessment of your cleaning program, that includes appropriate remediations to your cleaning processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning. Describe improvements to your cleaning program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning execution for all products and equipment; and all other needed remediations.
• Appropriate improvements to your cleaning validation program, with special emphasis on incorporating conditions identified as worst-case in your drug manufacturing operation. This should include, but not be limited to, identification and evaluation of all worst-case:
  o Drugs with higher toxicities
  o Drugs with higher drug potencies
  o Drugs of lower solubility in their cleaning solvents
  o Drugs with characteristics that make them difficult to clean
  o Swabbing locations for areas that are most difficult to clean
  o Maximum hold times before cleaning
  In addition, describe the steps that must be taken in your change management system before the introduction of new manufacturing equipment or a new product.
• A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.
• Process performance protocol(s), and written procedures for qualification of equipment and facilities and your program for qualification of your equipment and facility.

2. Your firm failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair (21 CFR 211.58).

You failed to adequately maintain your facility in a good state of repair. Specifically, we observed the following deficiencies during the inspection:

• Gaps were observed in the protective wall, covering the original underlying wall surface in the (b)(4) machine room, thus creating areas that are difficult to clean.
• An unknown brown-yellow material was visible in the wall gaps located near the (b)(4) equipment, indicating potential contamination risks in the manufacturing environment.
• A ceiling vent was improperly secured with transparent tape in the tablet room, demonstrating substandard facility maintenance practices.
• The walls of the room housing the (b)(4) were unfinished and not cleanable.

In your response, you state that you immediately halted all manufacturing operations and promptly took corrective actions to address the specific deficiencies. You also indicated that you would not resume manufacturing operations until all repairs were completed, and the rooms met the required standards for cleanliness and maintenance.

Your response is inadequate. You did not provide a systemic and comprehensive CAPA plan to ensure that your facility is and remains in a good state of repair.

It is essential that your facility be in a good state of repair to prevent contamination and to ensure its ongoing suitability for drug manufacturing.

In response to this letter, provide the following:

• Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review.
• Documented evidence (for example, photos) of any repairs made to your facilities and equipment.

Quality Systems

Your firm’s quality systems are inadequate. 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/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations.

CGMP Consultant Recommended

Because you failed to correct repeat violations, you should engage 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.

Repeat Observations at Facility

In previous inspections, dated July 18, 2018; February 11, 2022; and February 3, 2023, FDA cited similar CGMP observations, and you proposed specific remediation for these observations in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.

Conclusion

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

If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.

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 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.

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.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3008694072 and ATTN: Chhaya Shetty.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research