Recent FDA Warning Letter Notes Validation Failures for Aseptic and Sterilization Processes
The May 7, 2025 warning letter to Excelvision Fareva noted several departures from cGMP guidelines. One of them was: ‘Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR […]
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FDA Issued More Warning Letters in FY2023
In fiscal year 2023, FDA issued more warning letters than the year before. The agency issued 180 warning letters to drug and biologics companies, with 95 based on on-site audits. This was a rise from 165 warning letters in FY2022, with 74 audit-based. This increase in warning letters is a return to normal FDA operations […]
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CTK OTC Labs Hit With FDA Warning Letter For Not Conducting Batch Failure Investigations
FDA sent a warning letter to CTK OTC Labs, located in Corona, California, in June 2025 for not conducting thorough investigations into batch failures related to its manufacturing of topical creams and sunscreens. FDA investigators stated that CTK OTC Labs didn’t conduct sufficient investigations of out-of-specification (OOS) results for batches which had low potency values […]
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FDA Slams Huangshi Hygienic Material Medicine in Warning Letter
Huangshi Hygienic Material Medicine Co., a maker of OTC drugs in Huangshi City, China, received a warning letter in June 2025 for various cGMP violations. One of the most critical was failure to test products before their release (21 CFR 211.165(a)) as well as failing to affix the current expiration dates on products. FDA states […]
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New FDA AI Tool, Pushed by DOGE and Trump, Isn’t Going Well
Under pressure from the Trump Administration, FDA rolled out its artificial intelligence (AI) tool this week ahead of schedule, despite a 4% budget cut for FY 2025. The large language model (LLM) named Elsa, which was billed as a tool for FDA workers, is being criticized as buggy, overhyped, and inaccurate. An NBC report yesterday […]
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FDA Launches Widely-Anticipated AI Tool To Aid Scientific Reviewers and Investigators
It’s been a long time coming. Yesterday, FDA launched Elsa, an AI tool promised to help FDA employees work with greater efficiency. FDA says the tool will modernize various FDA functions and leverage AI capabilities to improve the drug and medical device improvement process. Elsa was built in a high-security cloud environment, offering a secure […]
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Recent FDA Warning Letters Highlight Common cGMP and CAPA Flaws
FDA keeps itself busy with handing out warning letters in 2025. This week, I noticed that FDA issued warning letters to a pharmaceutical company for not following cGMPs, and a diagnositic company for not implementing proper CAPAs. AACE Pharmaeuticals – May 13, 2025, Warning Letter A May 13 warning letter to AACE Pharmaceuticals stated that […]
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Wuxi Medical Instrument Factory in China Receives FDA Warning Letter
Wuxi Medical Instrument Factory of the Jiangsu province in China received an FDA warning letter on April 4, 2025, for cGMP violations the agency observed in a November 2024 inspection at the manufacturing faciity in Wuxi. The warning letter states that drugs were packed, prepared, or held in unsanitary conditions. This risked contamination with health […]
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FDA Slams Piramal API plant with 483 for problems in quality control, equipment cleaning
A year after an FDA reprimand at its Michigan manufacturing plant, Indian drugmaker Piramal Pharma faces scrutiny again following an inspection of its Maharashtra, India, facility from February 11 to 17. The FDA issued a six-observation 483, citing deficiencies in quality control, record-keeping, equipment maintenance, and more. The FDA criticized Piramal’s quality control unit for […]
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Aurobindo’s Ralieigh NC Plant Hit With 483
FDA conducted a cGMP inspection of Aurobindo Pharma Limited’s facility in Raleigh, NC from March 24 to April 10, 2025. Aurobindo’s facility produces inhalers and dermatology products, including topical creams and ointments. The company received an 11-item 483. Further details are noted below. FDA Form 483 Details Company Response Context and Historical Perspective Implications Sources
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