Sun Pharma yesterday said the US health regulator has issued a Form 483 with ten observations after inspecting its Halol-based manufacturing plant in Gujarat.
The US Food and Drug Administration (FDA) conducted a Good Manufacturing Practices (GMP) inspection of the Halol facility from 26th April to 9th May, 2022, the Mumbai-based drugmaker said in a regulatory filing.
“At the conclusion of the inspection, US FDA issued a Form-483, with 10 observations. The company is preparing the response to the observations, which will be submitted to US FDA within 15 business days,” it added.
The company is committed to addressing the observations promptly, Sun Pharma noted.
It remains committed to working closely with FDA and continues to enhance its GMP compliance on an ongoing basis, it added.
Edits by EP News Bureau