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USFDA issues warning letter to Sun Pharma over manufacturing at Dadra facility
Industry News- Jul 05,24
The warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals at the facility.
Sun Pharma failed to adequately clean and maintain equipment used for drug manufacturing at its Dadra plant, according to the USFDA. The health regulator inspected the facility in the Union Territory of Dadra and Nagar Haveli and Daman and Diu from December 4-15, 2023, and issued the warning letter to Dilip Shanghvi, Managing Director on June 18.
"Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements," the USFDA stated.
The warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals at the facility.
The USFDA also noted that the company's investigations of out-of-specification (OOS) results were inadequate, lacking scientific rationale for root cause determinations.
"Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed," the letter stated.
A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.
The USFDA also cited similar CGMP violations at the company’s other facilities, emphasising repeated failures at multiple sites. "You committed to conduct a comprehensive assessment of your global manufacturing operations across your company's network to ensure conformance to FDA requirements. These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate," the US health regulator stated.
The findings indicate that the drug firm does not operate an effective quality system in accordance with CGMP.
"We strongly recommend that your firm engage a consultant to assist your firm in meeting CGMP requirements," the USFDA stated.
"FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations," the USFDA said.
After receiving this letter, Sun Pharma must respond in writing within 15 working days, specifying the measures taken to address any deviations and prevent their recurrence.
The warning letter identifies the violation, such as poor manufacturing practices, problems with claims about a product's efficacy, or incorrect usage directions. It also makes clear that the company must correct the problem and provides directions and a timeframe for the corrections.
The USFDA will then verify if the company's corrective actions are adequate.
(Source: ET)
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