Cleaning Validation

EU GMP Non-Compliance: Glukem Biocare Private Limited – contamination risk in cleaned fluid-bed coating equipment

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After the inspection ending 15 September 2026, the Malta Medicines Authority considered the site non-compliant for non-sterile pellet manufacture and quality-control testing. A critical deficiency concerned contamination risk in cleaned fluid-bed coating equipment: liquid pooling and residue were observed in an inlet-air plenum. The authority linked this to a design that prevented gravity drainage and an inadequate cleaning procedure. There was also no real-time differential-pressure monitoring before and after the supply-air HEPA filter to detect integrity failure. Eleven major findings covered production records, process and cleaning validation, differential-pressure excursions, warehouse, sampling and dispensing controls, vendor qualification, starting-material identification, excipient risk assessments, OOS handling, equipment qualification and pest control. The authority stated that no site-manufactured batches should be released to EEA markets while the statement remains in place, unless superseded by an EU GMP certificate. Under the revocation heading, it recommended that member states consider not initiating or authorising new marketing authorisations listing the site; it did not state that existing authorisations were revoked. The authority said products should not be present in EEA markets and did not propose a teleconference.

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.

FDA Cites Stream2Sea for OTC Drug Manufacturing CGMP Violations

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FDA issued a warning letter to Stream2Sea LLC after a July 2025 inspection identified significant CGMP violations in finished OTC drug manufacturing. FDA cited inadequate final-product chemical and microbiological testing before batch release, including release before documented quality-unit approval. The agency also found missing identity testing of incoming components, reliance on supplier certificates of analysis without establishing supplier test reliability, and no supplier qualification program. FDA further cited inadequate cleaning validation and records for shared, non-dedicated equipment used for OTC drugs and cosmetics. It requested independent assessments, remediation plans, specifications, procedures, retrospective evaluations, and a written response within 15 working days.

FDA Warns Bentley Laboratories Over CGMP, Testing, and Validation Failures

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FDA issued a warning letter to Bentley Laboratories following a March 2026 inspection, citing significant CGMP violations for finished pharmaceuticals. FDA found inadequate investigations of out-of-specification stability and cleaning results, deficient root-cause analysis and CAPA, unjustified specification changes, and insufficient quality-unit oversight. The agency also cited inadequate incoming-component identity and impurity testing, reliance on supplier certificates of analysis without establishing reliability, and weaknesses in supplier qualification. Manufacturing and cleaning processes were not adequately validated or revalidated after changes, and validation protocols were not fully executed. FDA also determined that two acne products were unapproved new drugs and misbranded, and acknowledged the firm’s commitment to suspend certain OTC drug production.

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.