Quality Unit

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

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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

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

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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

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

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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.

FDA Warning Letter: Hanlim Pharm cited for sterile manufacturing and quality system deficiencies

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FDA cited significant CGMP violations following an April 2026 inspection of Hanlim Pharm’s drug manufacturing facility. Inspectors observed poor aseptic practices, including operators obstructing first air, working directly over exposed components, and wearing a visibly stained gown. Dynamic smoke studies did not demonstrate adequate unidirectional airflow protection and indicated possible entrainment of lower-quality air into the ISO 5 processing line. FDA also found that critical container-closure contact surfaces were wiped with sporicidal disinfectants rather than sterilized. Environmental monitoring locations and frequencies were not adequately justified or sufficient to detect contamination risks near containers, closures, and barriers facing ISO 5 areas. The visual inspection program lacked routine defect categorization and appropriate acceptance criteria despite significant defect rates. FDA further stated that the quality unit lacked adequate authority and oversight, citing failures involving the stability program and contemporaneous documentation of environmental and personnel monitoring data. FDA considered the company’s responses inadequate and noted similar violations in a previous warning letter.

FDA Warning Letter: Sterility, Component Testing, and Quality Unit Deficiencies at Jiangmen Shuizirun

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FDA states that its November 3–7, 2025, inspection of Jiangmen Shuizirun Sanitary Articles found significant CGMP violations in OTC drug manufacturing. Several products were labeled “sterile,” although they were not sterilized, the certificates of analysis did not claim sterility, and the firm did not perform release sterility testing. One released batch had a reported aerobic microbial count, which FDA said was unacceptable for a sterile-labeled drug. FDA also found inadequate identity and impurity testing for incoming components and purchased in-process materials, including high-risk ingredients, while supplier certificates were relied upon without establishing their reliability. The quality unit did not adequately oversee documentation, written production procedures, process and system validation, stability testing, or finished-product testing. FDA additionally noted that the same batch number was assigned to different products, and that neither the firm nor its U.S. Agent responded to FDA’s attempts to discuss recalling sterile-labeled products in U.S. distribution.

FDA cites CGMP violations at Jiangmen Shuizirun OTC drug facility

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FDA issued a warning letter to Jiangmen Shuizirun Sanitary Articles Co., Ltd. after a November 2025 inspection of its Chinese OTC drug manufacturing facility identified significant CGMP violations. FDA stated that products labeled “sterile” were not sterilized, lacked release sterility testing, and were assessed against microbial limits unacceptable for sterile drugs. The agency also cited inadequate identity and impurity testing of incoming components, reliance on supplier certificates without establishing reliability, and deficient quality-unit oversight of documentation, process validation, procedures, stability, and finished-product testing. FDA additionally identified non-unique batch numbering, recommended removal of within-expiry sterile-labeled products from the U.S. market, and noted that the firm’s drugs were placed on Import Alert 66-40.

FDA Warning Letter: Microbiological Data and Quality Unit Deficiencies at Eurofins SF Analytical Laboratories

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FDA states that its June 1–3, 2026 inspection of Eurofins SF Analytical Laboratories’ contract testing facility identified significant finished-drug CGMP violations in microbiological testing and quality oversight. Analysts did not record certain results assessed as too numerous to count and selectively documented results, while cracked and desiccated plates were reported as within limits or as 0 CFU. FDA also observed a colony on a plate recorded as 0 CFU. The procedure did not require secondary verification of initial zero counts, and compromised plates were discarded without secondary review. FDA found that aberrant media conditions were not thoroughly investigated; the firm’s retrospective conclusions relied on interviews and records it acknowledged were unreliable, without photographic evidence of plate conditions. FDA considered the response inadequate because it did not assess effects on certificates of analysis or customers, verify historical data completeness, or commit to discontinuing damaged plates. FDA further stated that the quality unit lacked adequate authority, oversight, and control over laboratory operations and requested independent assessments, CAPA, stronger investigation systems, sample custody controls, photographic documentation, and quality-unit remediation.

FDA Warning Letter: Microbiological OOS Investigations and Quality Unit Oversight at Silgan

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FDA inspected Silgan Unicep Packaging’s Spokane, Washington, drug manufacturing facility from March 26 to April 2, 2026, and reported significant CGMP violations involving non-sterile OTC products. FDA found that the firm inadequately investigated OOS microbiological results for components. Individual yeast and mold failures were invalidated by averaging sample results to obtain passing outcomes, and the sampling plan was revised to permit averaging, which FDA said was inconsistent with USP and could obscure non-uniform contamination. Affected component lots were released and used in distributed product. FDA also found the investigation associated with a Class I recall for potential fungal contamination inadequate: a bioburden-reduction corrective action was ineffective, related change control lacked appropriate validation and evaluation, the manufacturing line lacked cleaning procedures and cleaning validation, and environmental monitoring omitted yeast and mold testing. Separately, FDA said the quality unit failed to ensure supplier test reliability, follow the written stability program, and complete annual product reviews. FDA deemed the responses inadequate because they lacked sufficient scope, supporting evidence, effectiveness verification, product-risk measures, and remediation of systemic quality oversight failures.