FDA

FDA Posts CDER Compliance Records and Inspection Resources

by

The FDA CDER FOIA Electronic Reading Room page lists frequently requested or proactively posted compliance records for drugs. Its table identifies untitled letters and other correspondence by record date, FEI number where shown, firm, record type, country, and posting date. Listed firms include Neeyaan, Formulated Solutions, Port Jervis Laboratories, Chemspec Chemicals, Aptar Radolfzell, Amazon.com, Industria Farmaceutica Nova Argentia, Laurus Synthesis, Nectar Lifesciences, Shandong Boyuan Pharmaceutical, Silliker/Merieux NutriSciences, and Valisure. The page also directs users to FDA databases for inspections, drug-promotion untitled letters, Forms FDA 483, and establishment inspection reports. Content is marked current as of August 18, 2026.

FDA Closes Out NeilMed Pharmaceuticals Warning Letter

by

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: TSP Solutions cited for testing, supplier oversight, and quality unit deficiencies

by

FDA states that its review of records submitted by TSP Solutions identified significant CGMP violations involving sunscreen drug products. The firm did not demonstrate adequate finished-product testing before release. Submitted certificates of analysis and batch records lacked appropriate assays for active ingredient content, impurity testing, and appropriate microbiological testing. FDA also found that the firm did not demonstrate adequate identity testing of incoming components and accepted supplier certificates of analysis without verifying test results at appropriate intervals. Component quality verification consisted only of reviewing supplier certificates and material safety data sheets. In addition, FDA stated that the firm had not established an adequate quality unit with sufficient responsibilities and authority to oversee drug manufacturing. The quality unit failed to ensure adequate production and process control procedures, qualification of manufacturing equipment, laboratory control procedures, and an adequate ongoing stability program. FDA recommended a qualified CGMP consultant and a comprehensive six-system audit. The firm’s drugs were placed on Import Alert 66-40 on August 14, 2026.

FDA Warning Letter: Sanrace cited for component testing, process validation, and quality unit deficiencies

by

FDA’s records review of Sanrace Biotechnology found significant CGMP violations involving component testing, process control, and quality-unit oversight for OTC drug manufacturing. FDA states the firm did not demonstrate adequate identity testing of incoming components, including an active ingredient, and did not perform the USP identification test capable of detecting specified hazardous impurities on each shipment of each lot. FDA said this left the firm without scientific evidence that components met appropriate specifications before use. The firm’s response also stated that it had no process validation procedures or studies, so it did not demonstrate reproducible, controlled manufacturing yielding uniform quality. FDA further found that the quality unit was not established with adequate responsibility and authority over manufacturing. Cited examples included inadequate laboratory control procedures, an inadequate system monitoring program with insufficient attribute testing, and an inadequate ongoing stability program. Submitted records lacked complete stability data and testing for viscosity, pH, assay, and microbiological attributes throughout shelf life. FDA placed the firm’s drugs on Import Alert 66-40.

FDA discussion series addresses automation and quality at outsourcing facilities

by

FDA’s Compounding Quality Center of Excellence describes two discussion series for outsourcing facilities to share issues, practices and solutions intended to improve compounded drug quality. The New Outsourcing Facility Discussion Series is aimed at newly registered facilities and includes an “Automation Basics” session on November 18, covering automation types, potential efficiency and quality benefits, and implementation challenges. The Quality Discussion Series focuses on quality culture, best practices and current good manufacturing practice requirements. Its January 12, 2027 session addresses integrating automated systems for quality outcomes, including change management, quality considerations and maintaining CGMP requirements while pursuing efficiencies. The page is current as of October 21, 2026.

FDA Warning Letter: Baxter cited for cross-contamination and aseptic control failures

by

FDA states that its March 23–April 2, 2026, inspection of Baxter Healthcare Corporation’s Round Lake drug facility found significant CGMP violations in sterile injectable manufacturing. The facility did not achieve complete separation between cephalosporin and other drug production: environmental monitoring repeatedly detected cephalosporin outside the beta-lactam area, while sampling locations, swab recovery qualification, sample timing, and finished-product sampling were inadequate. Multiple failing environmental samples were mistakenly discarded. FDA also identified deficient aseptic controls, including recurring biological indicator growth accepted during requalification, insufficiently representative media fills, inadequate ISO 5 environmental monitoring, incomplete airflow visualization studies, and turbulent non-unidirectional airflow around processing equipment. Manual visual inspection was unreliable because operator qualification, challenge particles, and inspection speed were inadequate; particulate complaints included confirmed cardboard contamination. Investigations into rising container-closure leaks and a 2025 cefazolin sterility failure were also inadequate, and the sterility result was invalidated without adequate scientific justification before lot release. FDA found the company’s responses insufficient and its quality systems inadequate.

FDA Warning Letter: Rohto cited for falsified monitoring records and aseptic processing failures

by

FDA’s April 2026 inspection of Rohto-Mentholatum (Vietnam) Co., Ltd. identified significant CGMP violations in the manufacture of aseptically processed OTC ophthalmic drugs. FDA observed systemic falsification of environmental monitoring, personnel monitoring, and cleaning records, including submission of unexposed plates and documentation of cleaning that management confirmed was not performed. After FDA discussed these deficiencies with management, monitoring conducted during the inspection produced numerous samples with microbial growth, including approximately 25 ISO 5 excursions. FDA also observed poor aseptic practices, undocumented interventions, deficient gowning, reuse of opened sterile component bags, infrequent decontamination, inadequate supervisory oversight, and equipment placement that obstructed unidirectional airflow. Investigations of two batches exceeding visual-inspection reject limits did not adequately identify the nature or source of particles, yet the batches were released to the U.S. market. FDA found the company’s response inadequate, citing reliance on unreliable monitoring data and insufficient consideration of systemic data integrity failures. The company subsequently initiated recalls due to lack of sterility assurance and suspended U.S.-market production.

FDA Warning Letter: Component Testing and Quality Unit Deficiencies at Zhejiang Gaorong Cosmetic

by

FDA identified significant CGMP violations during a review of records submitted by Zhejiang Gaorong Cosmetic Co., Ltd., an OTC drug manufacturer. The firm did not demonstrate adequate testing of every shipment of each incoming component lot before use. Documentation lacked adequate identity and impurities testing for redacted components described as being at risk or high risk for contamination. The firm also accepted active pharmaceutical ingredients based on supplier certificates of analysis without establishing the reliability of supplier testing at appropriate intervals. FDA stated that this left the firm without scientific evidence that components or drug products met appropriate specifications before use. FDA also found that the quality unit did not effectively oversee drug manufacturing operations, including ensuring complete batch-production records and adequate stability data supporting product expiry. FDA requested component testing and supplier-reliability plans, contract laboratory oversight, risk assessment and testing for implicated materials and products, supplier and material-system review, and comprehensive quality-unit remediation.

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

by

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 Warning Letter: Signature Formulations cited for systemic cross-contamination and quality system failures

by

FDA states that laboratory testing of (b)(4) lots of contract-manufactured (b)(4) drug products found contamination in every lot tested, including undeclared (b)(4) above the stated limit of quantitation and, in many cases, at far higher levels. The agency linked the findings to manufacturing (b)(4) products in the same environment on shared equipment. FDA said residues from the active ingredients would not be adequately removed from shared surfaces and equipment under standard cleaning conditions and that the firm had not established appropriate design and control procedures to prevent hazardous cross-contamination. Because contamination was confirmed across all randomly sampled lots, FDA characterized the problem as systemic, nonuniformly distributed, and not resolvable through retrospective testing. FDA also cited insanitary conditions, ineffective management oversight, and a quality unit lacking sufficient authority or implementation of its responsibilities. FDA recommended recall of all distributed drug products; the firm verbally committed to halt manufacturing and distribution and recall all (b)(4) drug products. FDA also noted a 2025 recall for contamination.