CAPA

FDA Closes Out NeilMed Pharmaceuticals Warning Letter

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FDA issued a closeout letter to NeilMed Pharmaceuticals Inc., referencing FEI 3002998723 and drug products, after evaluating the firm’s corrective actions responding to a Warning Letter dated May 26, 2023. FDA stated that the firm appears to have addressed the violations cited in that Warning Letter. The agency noted that future inspections and regulatory activities will further assess the adequacy and sustainability of the corrections. FDA also emphasized that the closeout letter does not remove the firm’s responsibility to sustain compliance with the Federal Food, Drug, and Cosmetic Act, implementing regulations, and other relevant legal authority, and does not preclude future regulatory action if violations are later observed.

FDA Warning Letter: SnugZ USA cited for OOS, laboratory, supplier, and quality unit deficiencies

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FDA states that its April 27 to May 1, 2026 inspection of SnugZ USA’s OTC drug manufacturing facility identified significant CGMP violations. The firm routinely failed to investigate out-of-specification chemical and microbiological results, instead retesting or preparing new samples until passing results were obtained and using those results for product release. Complaint investigations lacked adequate root cause determinations and CAPA. Laboratory procedures permitted repeated testing without investigations and allowed analysts discretion regarding unidentified chromatographic peaks. FDA also found unsupported tiered microbiological testing, with failing results invalidated in favor of passing results from a second instrument. Incoming components were not adequately identity-tested or representatively sampled, and supplier certificates of analysis were accepted without establishing their reliability through confirmatory testing. FDA further states that the quality unit did not adequately oversee manufacturing, testing, records, investigations, release decisions, cleaning validation, or product quality reviews. Similar investigation and laboratory-control deficiencies had been observed previously, and FDA considered the firm’s remediation responses insufficiently detailed and sustainable.

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.

FDA Cites Curia New York for API Data Integrity and Computerized System Failures

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FDA issued a warning letter to Curia New York, Inc. after its January 28–February 5, 2026 inspection of the Rensselaer API manufacturing facility. It states the firm’s APIs are adulterated because manufacturing methods, facilities, or controls did not conform to CGMP. FDA cited incomplete laboratory records and thousands of unexplained HPLC/UPLC injections, including use of the Empower “Developer” role; discarded original records and review of photocopies; and shared computerized-system credentials. FDA found the firm’s responses inadequate in scope or supporting evidence. It requested independent investigations, retrospective data-integrity and computerized-system assessments, product-impact and risk evaluations, laboratory remediation, and a global CAPA plan.

FDA Cites Sterile Injectable CGMP Violations at Fresenius Kabi Facility

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FDA issued a warning letter to Fresenius Kabi AG after a January 27 to February 18, 2026 inspection identified significant CGMP violations at its Melrose Park sterile injectable facility. FDA cited inadequate investigations of endotoxin and bioburden signals, media fill failures, complaints, and biological particulate contamination; deficient aseptic process simulations and cleanroom practices; and inadequate visual inspection, facility, and equipment controls. The letter states that investigations overrelied on passing finished-product tests and lacked supported root causes, broad scope, and CAPA effectiveness checks. It also describes recalls of three famotidine injection batches and, following FDA discussions, six batches of other injectable products. FDA requested independent assessments, retrospective reviews, remediation plans, and a response within 15 business days.

FDA Warning Letter: Fresenius cited for leaking dialysis solution bags and inadequate visual inspection controls

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FDA inspected Fresenius USA Manufacturing’s Ogden, Utah drug facility from March 2-6, 2026, and cited significant CGMP violations involving complaint investigations, CAPA, process controls, and visual inspection of sterile injectable products. For Delflex Peritoneal Dialysis Solution, an August 2025 investigation covered 35 complaints involving approximately 156 leaking bags from multiple batches and attributed holes to printing. FDA stated that the firm assigned the lowest severity despite its matrix identifying peritonitis as a potential harm at the highest severity, did not recall then, and inadequately investigated risk and implemented CAPA. After inspection, reexamination found perforations without substantial fluid in the overwrap; the firm reassessed risk and recalled affected lots on April 6, 2026 for lack of assurance of sterility. FDA found the response still lacked sufficient CAPA to improve leak detection. FDA also found personnel qualification for visual particulate inspection inadequate because the kit was not adequately representative and records lacked sufficient detail, and said the response did not demonstrate reliable detection at an appropriate level.

FDA and PDA Announce 2026 Joint Regulatory Conference

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FDA and the Parenteral Drug Association (PDA) will host the 2026 PDA/FDA Joint Regulatory Conference, “Excellence in CGMP: Ensuring Quality, Protecting Patients,” in Washington, D.C., from September 14 through 16, 2026. The program is intended to provide practical insights on CGMP compliance, quality systems, risk-based manufacturing, supply chain oversight, and industrial modernization through expert discussions and case studies. Listed subjects include FDA center and office updates, artificial intelligence in regulatory oversight and inspection readiness, pre-approval inspections, CAPA and effectiveness checks, data governance, quality risk management, change management, workforce development, CGMP training, and global regulatory collaboration. Registration and a full agenda are available through PDA.