The US Food and Drug Administration (USFDA) has issued a Form 483 with four observations to Piramal Pharma following an inspection of its Digwal manufacturing facility in Telangana.
The inspection was conducted between February 9 and February 13, 2026, at the company’s plant located in Telangana. At the conclusion of the review, the US regulator issued Form 483, citing four observations related to procedural enhancements.
According to the company’s regulatory filing, the observations are not linked to data integrity issues and have been classified as Voluntary Action Indicated (VAI). This classification suggests that while certain improvements are required, the findings do not warrant immediate regulatory action or enforcement measures.
Piramal Pharma stated that it is preparing a detailed response to address the observations and will submit it to the USFDA within the stipulated timeline. The company reiterated its commitment to maintaining high compliance standards and said it will work closely with the regulator to resolve the issues comprehensively.
As per USFDA guidelines, a Form 483 is issued at the end of an inspection when investigators identify conditions that may potentially violate provisions of the US Food, Drug and Cosmetic (FD&C) Act and related regulations.
The development highlights ongoing regulatory scrutiny in the pharmaceutical sector, even as companies continue to strengthen quality and compliance frameworks at manufacturing facilities catering to global markets.
USFDA Flags 4 Procedural Observations at Piramal Pharma’s Telangana Plant
