Piramal Pharma's Telangana Unit Issued USFDA Form 483 Citing Four Observations

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USFDA Issues Form 483 with 4 Observations to Piramal Pharma's Telangana Unit

Piramal Pharma

M

Moneycontrol•14-02-2026, 14:22

USFDA Issues Form 483 with 4 Observations to Piramal Pharma's Telangana Unit

•USFDA issued a Form 483 with four observations to Piramal Pharma's manufacturing plant in Digwal, Telangana.
•The inspection took place from February 9 to February 13, 2026.
•Observations relate to procedural enhancements, not data integrity, and are classified as VAI (voluntary action indicated).
•Piramal Pharma is preparing a detailed response to be submitted to the USFDA within stipulated timelines.
•The company reaffirms its commitment to compliance and will address all observations.

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