Last Updated on November 11, 2024 by The Health Master
US Food and Drug Administration (USFDA) completed its inspection of the Piramal Pharma, Digwal facility with zero Form-483 observations.
The USFDA issues a Form 483 when a facility fails to comply with the regulator’s manufacturing norms.
Domestic pharmaceutical companies have suffered the consequences of heightened regulatory scrutiny from the US drug regulator in the past few months after physical inspections restarted as coronavirus ebbed.
Issuance of Form 483 also causes a delay in the launch pipeline for drugs to the US market, which makes up a significant portion of revenues for several Indian drugmakers.
The USFDA conducted a Good Manufacturing Practices inspection of Piramal Pharma’s Digwal facility during March 27-31.
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