The US FDA has completed a general Good Manufacturing Practices (GMP) inspection of Piramal Pharma Limited’s Lexington (Kentucky, USA) facility, which took place from December 3rd to 10th, 2025. Following the inspection, a Form-483 was issued, noting four observations related to procedural enhancements. Piramal Pharma is preparing a detailed response to address these observations and will submit it to the FDA within the given timelines.
FDA Inspection Concludes
Piramal Pharma Limited has announced the completion of the US FDA’s general Good Manufacturing Practices (GMP) inspection at its Lexington, Kentucky (USA) facility. The inspection spanned from December 3rd, 2025, to December 10th, 2025.
Form 483 Issued
Upon conclusion of the inspection, the US FDA issued a Form-483, identifying four observations. These observations are related to areas for enhancement in procedures and will be classified as VAI (voluntary action indicated).
Company Response
Piramal Pharma is currently preparing a detailed response to the FDA’s observations and is committed to submitting it within the stipulated timelines. The company reaffirms its commitment to maintaining the highest standards of compliance and will work collaboratively with the agency to comprehensively address all observations.
Source: BSE
