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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA has issued a Warning letter to Glenmark Pharma’s Pithampur manufacturing facility (FEI 3008565058). The facility was inspected in February 2025 by USFDA investigators Tamil Arasu and Saleem A Akhtar.
The inspection revealed several critical deficiencies particularly concerning the manufacturing of non-penicillin beta-lactam drugs in shared facilities and inadequate cleaning and verification processes. FDA expects facilities or sections manufacturing beta-lactam products must be dedicated, isolated and comprehensively separated from other non-beta-lactam manufacturing areas as any contamination presents great risk to patient safety. FDA has issued specific guidance for preventing cross contamination during manufacture of Non-Penicillin Beta-Lactam Drugs.
Further critical observations included lapses in handling of Out of specification (OOS) investigations and delayed Stability Studies. The root causes for OOS incidents were not adequately supported, with several OOS results attributed to analyst error. It was also observed extraneous peaks recorded during several instances of dissolution, assay and content uniformity testing were not identified. The FDA consistently emphasizes that in OOS investigations simply citing analyst error is insufficient; investigations must uncover the underlying conditions causing the OOS. Firms are expected to prioritize stability studies, even over batch release tests, as these are critical to assuring the safety and integrity of already distributed batches.
In a statement to stock exchanges, Glenmark clarified that the Warning Letter contains no critical observations related to data integrity. The company reiterated its commitment to addressing the concerns raised by the USFDA at the earliest.
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