FDA

FDA Warning Letter: Pine Pharmaceuticals cited for aseptic control, investigation, and validation deficiencies

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FDA inspected Pine Pharmaceuticals’ outsourcing facility from November 4–14, 2025, and found evidence of insanitary conditions and CGMP violations in production of drugs intended to be sterile. Operators did not sanitize materials, equipment, hands, or sleeves appropriately when moving from the ISO 7 area into the ISO 5 critical area. FDA also found that routine environmental monitoring did not cover manually handled, high-touch staging trays with a difficult-to-clean design. The letter cites inadequate investigations, deficient aseptic and sterilization process procedures and validation, inadequate personnel qualification, and deficient yield and reject-rate controls. FDA said particulate defects could bypass investigation triggers, while undefined “cosmetic” defects could be returned to batches. Responses were considered unsupported or deficient, including failure to establish root causes for particulates and recurring closure or inspection defects, reliance on reinspection and retrospective risk assessments, and incomplete CAPAs. FDA also found inadequate change control and requalification of visual inspectors, incomplete reject-rate corrections, and undefined, operator-dependent mixing parameters without a detailed validation plan.

FDA Warning Letter: Inadequate Testing, Process Validation, and Quality Unit Oversight at TCI BioCosme

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FDA states that its March 2026 inspection identified significant CGMP violations in the manufacture of OTC drug products. The firm released U.S.-market batches without finished-product assay testing for the active ingredient, and its quality system did not ensure that required tests were identified, documented, and completed. FDA also observed inadequate identity testing of incoming APIs and raw materials, reliance on supplier certificates of analysis without establishing their reliability, and failure to perform applicable USP monograph tests. Manufacturing processes were not adequately validated: a validated process differed from the batch record, and validation for one product was used to support another product with a different process. Qualification and monitoring of a component used in products and equipment cleaning lacked specified chemical and microbial testing and defined microbial limits. FDA further cited inadequate quality unit oversight, including undocumented process-parameter changes, deficient batch records, and the absence of a written stability testing program. FDA found the firm’s Form FDA 483 response inadequate because it lacked sufficient supporting documentation and evidence of corrective actions.

FDA Warning Letter: Unapproved CHLA:10M Drug Marketed for Chlamydia Symptom Relief

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FDA reviewed DesBio/Deseret Biologicals’ website in July 2026 and determined that CHLA:10M was marketed as a drug for temporary relief of symptoms associated with chlamydia infection. FDA cited labeling claims concerning burning during urination, testicular tenderness or pain, vaginal discharge, and painful sexual intercourse. The agency stated that CHLA:10M was a new drug because it was not generally recognized as safe and effective for its labeled conditions of use, and no approved application was in effect for the product. FDA therefore concluded that its introduction or delivery for introduction into interstate commerce violated the FD&C Act. Although the labeling described CHLA:10M as homeopathic, FDA noted that its listed ingredient, Chlamydia trachomatis 10M, was not listed in the Homeopathic Pharmacopeia of the United States. FDA requested a written response describing corrective and preventive measures. The letter reports a website review and does not describe an inspection or identify manufacturing, laboratory, validation, contamination-control, data-integrity, facility, or other CGMP observations.

FDA Closes Out Glenmark Pharmaceuticals Warning Letter

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FDA issued a closeout letter to Glenmark Pharmaceuticals Limited on September 23, 2026, after evaluating corrective actions submitted in response to Warning Letter 320-23-04, dated November 22, 2022. The agency stated that the company appears to have addressed the violations identified in that warning letter. FDA said future inspections and regulatory activities will further assess the adequacy and sustainability of the corrections. It also emphasized that the closeout does not remove the firm’s responsibility to maintain compliance and does not prevent future regulatory action if violations are later observed. The letter concerns drug operations at the Colvale, Goa site.

Greenwich Rx Recalls Compounded Glutathione for Potential Elevated Endotoxin

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Greenwich Rx, a 503A compounding pharmacy, announced a voluntary nationwide consumer-level recall of ten lots of compounded glutathione injection 200 mg/mL in 10 mL multidose vials because of potential elevated endotoxin levels. The affected product was intended for subcutaneous injection and was distributed to patients from June 26 through September 21, 2026, with beyond-use dates from October 2 through November 12, 2026. The stated risks include fever, hypotension, inflammatory reactions, anaphylactic shock, and death. The company reported that two patients required emergency department care after intravenous administration of a glutathione product not formulated for IV use. Customers were instructed to stop using recalled product and follow disposal directions. The recall is being conducted with FDA’s knowledge.

FDA Drug Guidance Resources and Search Information

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FDA’s Guidances | Drugs page explains that guidance documents reflect the Agency’s current thinking on particular subjects, do not create or confer rights, and do not bind FDA or the public. It states that alternative approaches may be used when they satisfy applicable statutory or regulatory requirements. The page directs users to FDA’s guidance search, including filtering by the Center for Drug Evaluation and Research and other criteria. It lists drug-related categories such as Chemistry, Manufacturing, and Controls, Current Good Manufacturing Practice, ICH-Quality, Microbiology, Pharmaceutical Quality, Compliance, and Electronic Submissions. It also links to withdrawn guidances, the CDER Guidance Agenda, product-specific guidances, Spanish translations, and good guidance practices resources.

FDA Warning Letter: Babikian Healthcare Products cited for component, finished-product, and quality-unit deficiencies

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FDA reviewed records submitted by Babikian Healthcare Products CJSC in response to an August 12, 2025 request and identified significant CGMP violations involving its OTC drug manufacturing operations. The firm did not test the identity of each incoming component or validate the reliability of suppliers’ certificates of analysis at appropriate intervals. FDA also found no evidence that specified active ingredients met referenced USP limits. Finished-product reports lacked appropriate assay testing for active-ingredient identity and strength and for impurities; records also failed to demonstrate adequate microbiological testing for each batch before release. FDA stated that the quality unit did not adequately exercise its authority and responsibilities. It failed to ensure written production and process-control procedures for process performance and qualification of a system producing a component, complete manufacturing information in batch records, stability data supporting labeled expiration dates, and adequate quality-unit authority and procedures. FDA characterized the quality systems as inadequate and stated that the drug products were adulterated because manufacturing methods, facilities, or controls did not conform to CGMP.

FDA Warning Letter: VeganicSKN OOS, Component Testing, and Quality Unit Deficiencies

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FDA stated that its July 2025 inspection of VeganicSKN Limited found significant CGMP violations. The firm delayed a Phase II investigation of an out-of-specification result from August 2024 until December 2024, released and shipped the batch after passing retest results, and closed the investigation in July 2025 without determining a root cause. FDA found the response inadequate because it did not justify the nearly 11-month investigation or comprehensively assess other OOS investigations. FDA also observed inadequate identity testing of a high-risk incoming component, reliance on supplier certificates of analysis without establishing their reliability, and use of an expired raw-material lot. The response did not adequately address affected distributed products, other at-risk components, or interim controls. FDA further stated that the quality unit lacked adequate authority, procedures, and oversight; production personnel performed functions that should be quality-assurance responsibilities, and bulk hold-time validation studies were not completed. FDA also raised concerns about closely integrated entities sharing facilities, utilities, equipment, systems, personnel, and management.

FDA Cites Stream2Sea for OTC Drug Manufacturing CGMP Violations

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FDA issued a warning letter to Stream2Sea LLC after a July 2025 inspection identified significant CGMP violations in finished OTC drug manufacturing. FDA cited inadequate final-product chemical and microbiological testing before batch release, including release before documented quality-unit approval. The agency also found missing identity testing of incoming components, reliance on supplier certificates of analysis without establishing supplier test reliability, and no supplier qualification program. FDA further cited inadequate cleaning validation and records for shared, non-dedicated equipment used for OTC drugs and cosmetics. It requested independent assessments, remediation plans, specifications, procedures, retrospective evaluations, and a written response within 15 working days.

FDA Warns Bentley Laboratories Over CGMP, Testing, and Validation Failures

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FDA issued a warning letter to Bentley Laboratories following a March 2026 inspection, citing significant CGMP violations for finished pharmaceuticals. FDA found inadequate investigations of out-of-specification stability and cleaning results, deficient root-cause analysis and CAPA, unjustified specification changes, and insufficient quality-unit oversight. The agency also cited inadequate incoming-component identity and impurity testing, reliance on supplier certificates of analysis without establishing reliability, and weaknesses in supplier qualification. Manufacturing and cleaning processes were not adequately validated or revalidated after changes, and validation protocols were not fully executed. FDA also determined that two acne products were unapproved new drugs and misbranded, and acknowledged the firm’s commitment to suspend certain OTC drug production.