Process Validation

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.

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: Pine Pharmaceuticals cited for aseptic control, investigation, and validation deficiencies

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FDA inspected Pine Pharmaceuticals’ outsourcing facility from November 4–14, 2025, and found evidence of insanitary conditions and CGMP violations in production of drugs intended to be sterile. Operators did not sanitize materials, equipment, hands, or sleeves appropriately when moving from the ISO 7 area into the ISO 5 critical area. FDA also found that routine environmental monitoring did not cover manually handled, high-touch staging trays with a difficult-to-clean design. The letter cites inadequate investigations, deficient aseptic and sterilization process procedures and validation, inadequate personnel qualification, and deficient yield and reject-rate controls. FDA said particulate defects could bypass investigation triggers, while undefined “cosmetic” defects could be returned to batches. Responses were considered unsupported or deficient, including failure to establish root causes for particulates and recurring closure or inspection defects, reliance on reinspection and retrospective risk assessments, and incomplete CAPAs. FDA also found inadequate change control and requalification of visual inspectors, incomplete reject-rate corrections, and undefined, operator-dependent mixing parameters without a detailed validation plan.

FDA Warning Letter: Inadequate Testing, Process Validation, and Quality Unit Oversight at TCI BioCosme

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FDA states that its March 2026 inspection identified significant CGMP violations in the manufacture of OTC drug products. The firm released U.S.-market batches without finished-product assay testing for the active ingredient, and its quality system did not ensure that required tests were identified, documented, and completed. FDA also observed inadequate identity testing of incoming APIs and raw materials, reliance on supplier certificates of analysis without establishing their reliability, and failure to perform applicable USP monograph tests. Manufacturing processes were not adequately validated: a validated process differed from the batch record, and validation for one product was used to support another product with a different process. Qualification and monitoring of a component used in products and equipment cleaning lacked specified chemical and microbial testing and defined microbial limits. FDA further cited inadequate quality unit oversight, including undocumented process-parameter changes, deficient batch records, and the absence of a written stability testing program. FDA found the firm’s Form FDA 483 response inadequate because it lacked sufficient supporting documentation and evidence of corrective actions.

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: VeganicSKN OOS, Component Testing, and Quality Unit Deficiencies

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FDA stated that its July 2025 inspection of VeganicSKN Limited found significant CGMP violations. The firm delayed a Phase II investigation of an out-of-specification result from August 2024 until December 2024, released and shipped the batch after passing retest results, and closed the investigation in July 2025 without determining a root cause. FDA found the response inadequate because it did not justify the nearly 11-month investigation or comprehensively assess other OOS investigations. FDA also observed inadequate identity testing of a high-risk incoming component, reliance on supplier certificates of analysis without establishing their reliability, and use of an expired raw-material lot. The response did not adequately address affected distributed products, other at-risk components, or interim controls. FDA further stated that the quality unit lacked adequate authority, procedures, and oversight; production personnel performed functions that should be quality-assurance responsibilities, and bulk hold-time validation studies were not completed. FDA also raised concerns about closely integrated entities sharing facilities, utilities, equipment, systems, personnel, and management.

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: Fresenius cited for leaking dialysis solution bags and inadequate visual inspection controls

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FDA inspected Fresenius USA Manufacturing’s Ogden, Utah drug facility from March 2-6, 2026, and cited significant CGMP violations involving complaint investigations, CAPA, process controls, and visual inspection of sterile injectable products. For Delflex Peritoneal Dialysis Solution, an August 2025 investigation covered 35 complaints involving approximately 156 leaking bags from multiple batches and attributed holes to printing. FDA stated that the firm assigned the lowest severity despite its matrix identifying peritonitis as a potential harm at the highest severity, did not recall then, and inadequately investigated risk and implemented CAPA. After inspection, reexamination found perforations without substantial fluid in the overwrap; the firm reassessed risk and recalled affected lots on April 6, 2026 for lack of assurance of sterility. FDA found the response still lacked sufficient CAPA to improve leak detection. FDA also found personnel qualification for visual particulate inspection inadequate because the kit was not adequately representative and records lacked sufficient detail, and said the response did not demonstrate reliable detection at an appropriate level.

FDA Warning Letter: Spa De Soleil cited for water system, component testing, validation, and quality unit deficiencies

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FDA inspected Spa De Soleil’s Sun Valley drug manufacturing facility in January 2026 and found significant CGMP violations affecting OTC topical drug production. FDA states the firm inadequately investigated 51 water-system microbiological OOL and chemical OOS results recorded from May 2024 through July 2025, including gram-negative recoveries, conductivity failures, and total organic carbon failures. Investigations relied on resampling and retesting without identifying microorganisms or adequately evaluating affected products. The water system contained dead legs, threaded fittings, Teflon tape, and ball valves, and monitoring did not reflect production schedules. FDA also found inadequate identity and impurity testing of incoming high-risk components, including controls for methanol, DEG, and EG, plus unverified reliance on supplier certificates of analysis. Manufacturing processes lacked adequate validation, and batch records omitted critical processing parameters and equipment identification. An alternative microbiological method was not shown equivalent to or better than USP methods. FDA further cited ineffective quality-unit oversight, insufficient contract-laboratory qualification, absent annual product quality evaluations, and unvalidated cleaning procedures. The February 2026 response lacked supporting documentation and adequate corrective-action evidence; similar violations had been cited in 2021.