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The US Food and Drug Administration (USFDA) conducted a Good Manufacturing Practices (GMP) inspection at Shilpa Medicare Limited's Unit VI in Dabaspet, Bengaluru, India. The inspection took place over three separate days: October 24th and 25th, and again from October 28th to 30th, 2024. This particular unit of Shilpa Medicare Ltd. specializes in the production, testing, and release of Oral Mouth Dissolving Films and Transdermal Systems.
At the conclusion of the inspection, the USFDA issued Form 483, which outlines observations made during the GMP assessment. Notably, the four observations mentioned in the Form 483 are all characterized as procedural in nature. This implies that the issues identified are related to processes or documentation rather than fundamental problems with the manufacturing processes themselves.
The company has been directed to respond to these observations within a specific timeframe. This response will likely involve detailed explanations of the corrective actions that Shilpa Medicare Ltd. plans to implement to address the USFDA's concerns. The company's ability to provide a satisfactory response and demonstrate adherence to GMP regulations will be crucial in maintaining its manufacturing authorization and ensuring continued access to the US market.