Cleaning Validation

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.