Piramal Pharma Limited has announced the conclusion of a Good Manufacturing Practices (GMP) inspection by the US FDA at its Sellersville (USA) facility. The inspection, conducted from May 4, 2026, to May 8, 2026, resulted in the issuance of a Form-483 containing three observations. Importantly, the company confirmed that none of the findings relate to data integrity, and the inspectors recommended a Voluntary Action Indicated (VAI) classification.
Inspection Outcome
Following a recent audit of the Sellersville (USA) manufacturing site, the US FDA concluded its review process on May 8, 2026. The agency issued a Form-483 identifying three observations. During the closing meeting, inspectors recommended that these items be classified as Voluntary Action Indicated (VAI), which typically signifies that the observations are of a nature that the company can address through corrective actions.
Commitment to Compliance
Piramal Pharma has confirmed that no data integrity issues were identified during the course of the inspection. The management is currently finalizing a detailed response plan to address the observations noted by the agency. This response will be formally submitted to the US FDA within the required stipulated timelines. The company maintains its commitment to upholding high manufacturing and compliance standards across its global operations.
Source: BSE
