Stability

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: 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: KDC/ONE Chatsworth cited for testing, OOS investigation, and storage deficiencies

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FDA inspected KDC/ONE Chatsworth’s drug manufacturing facility from March 31 to April 3, 2026, and cited significant CGMP violations involving OTC finished pharmaceuticals. The agency states that the firm lacked scientifically sound finished-product specifications and did not perform specified contaminant testing at release or during stability studies, despite known degradation and reaction pathways and notification of contamination linked to products recalled in Canada. FDA said the firm did not determine whether recalled batches reached the United States, assess U.S. consumer risk, identify other potentially affected batches, or demonstrate that its proposed third-party laboratory was qualified. FDA also observed inadequate investigations of viscosity OOS stability results, including insufficient root-cause determination, CAPA, specification justification, and risk assessment for distributed products. In addition, FDA found inadequate warehouse temperature monitoring and procedures, including storage above labeled conditions and internal limits. FDA considered the firm’s responses inadequate and stated that the quality unit was not able to fully exercise its authority and responsibilities.

FDA Warning Letter: Happy Farm Botanicals cited for component testing, stability, and validation failures

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FDA states that its March 30 to April 2, 2026, inspection of Happy Farm Botanicals’ OTC drug facility found significant CGMP violations. The firm did not perform specific identity testing on incoming raw materials and components, including APIs, before use; one API lot received only organoleptic testing and was used in finished batches. FDA also found a lapsed supplier requalification and no adequate validation of supplier test analyses. The stability program lacked adequate chemical and microbiological support for labeled expiry periods: accelerated studies lacked controlled humidity records, several timepoints were unavailable, and failing viscosity results in accelerated and long-term studies were not investigated. FDA’s quality unit findings included absent process validation for OTC products, absent cleaning validation for non-dedicated equipment, inadequate investigation and CAPA for recurring gasket seal failures, and inappropriate API content release limits. FDA deemed the firm’s response inadequate and noted that process and cleaning validation commitments from the 2024 inspection remained incomplete. The firm reported plans to cease production of the specified drugs at this facility.

FDA Warning Letter: Insanitary API Manufacturing, Incomplete Laboratory Data, and Weak Quality Oversight

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FDA states that its April 13 to 17, 2026 inspection of Shoolin Pharma Chem LLP found APIs prepared, packed, or held under insanitary conditions and identified significant API CGMP violations. Investigators observed layered unidentified residues, chemical residues and stains on walls, floors, equipment, and product-contact areas; corroded or apparently rusted surfaces; leaking lines; improperly stored transfer lines; and an employee wearing open-toed sandals near open equipment during production. Nondedicated equipment was used for multiple APIs. FDA also found inadequate written cleaning and maintenance procedures, no swab or rinse cleaning verification, and insufficient cleaning validation remediation. The firm could not provide raw data supporting certificate-of-analysis results, while contract-laboratory results were reported on company letterhead without identifying the original laboratory. Stability chambers were powered off or outside temperature or humidity conditions, supporting records were unavailable, and tadalafil samples were missing. FDA further cited inadequate quality-unit oversight of impurity risks, contract laboratories, process validation, equipment calibration, materials testing, and annual product reviews. The firm recalled all APIs distributed in the U.S., and FDA placed its drugs on Import Alert 66-40.

FDA Warning Letter: API Process Validation, Batch Records, Analytical Methods, and Stability Deficiencies

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What happened FDA states that its records review identified significant CGMP deviations at Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd., an API manufacturer. The firm manufactured and distributed APIs to U.S. 503A compounding pharmacies without adequate process validation; it had described the APIs as still in development and said formal documents, including SOPs, were not finalized. … Read more