USFDA grills Sun Pharma for manufacturing issues at Dadra facility

4 Jul 2024 , 11:24 AM

According to the US Food and Drug Administration, Sun Pharma failed to clean and maintain medicine manufacturing equipment at its Dadra site.

In a warning letter to the company’s Managing Director Dilip Shanghvi dated June 18, the US health regulator stated that it examined the factory in the Union Territory of Dadra and Nagar Haveli and Daman and Diu from December 4 to 15, 2023.

The USFDA stated that the company failed to clean, maintain, and as necessary for the nature of drug, sanitise and/or sterilise equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would modify the identity, strength, safety, and quality of products beyond the official or other established requirements.

The warning letter detailed substantial violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals at the facility.

The USFDA also stated that the company’s inquiries into out-of-spec (OOS) results were insufficient because they lacked scientific justification for root cause determinations.

“Your firm failed to thoroughly investigate any unforeseen discrepancy or failure of a batch or any of its parts to meet any of its requirements, regardless of whether or not the batch has already been distributed,” according to this report.

When the US health regulator determines that a manufacturer has seriously broken its regulations, it issues a warning letter.

The USFDA also found similar CGMP breaches at the company’s other sites.

At around 11.16 AM, Sun Pharma was trading 0.98% higher at ₹1,549 per piece, against the previous close of ₹1,533.90 on NSE. The counter touched an intraday high and low of ₹1,551, and ₹1,526, respectively.

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