Piramal Pharma's Telangana Plant Receives USFDA Observations: Next Steps

Piramal Pharma has received a Form 483 from the USFDA following an inspection of its Telangana plant. The form includes four observations related to procedural improvements, classified as voluntary action indicated (VAI). The company is preparing a response to address the observations and ensure compliance.

Piramal Pharma's manufacturing facility in Telangana has come under the spotlight after a recent visit by the US Food and Drug Administration (USFDA) resulted in a Form 483 issuance. The inspection, which took place from February 9 to February 13, 2026, concluded with four observations noted by inspectors.

These observations focus on procedural enhancements rather than data integrity issues, marking them as a voluntary action indicated (VAI). The company is actively working on a comprehensive response to the USFDA's findings, to be submitted within the required timelines.

Piramal Pharma has reiterated its commitment to upholding stringent compliance standards and intends to collaborate extensively with the USFDA to thoroughly resolve all identified observations. This incident once again underscores the critical importance of regulatory adherence in the pharmaceutical industry.

(With inputs from agencies.)