New Delhi: sun pharma failed to adequately clean and maintain the equipment used Drug manufacturing According to the US Food and Drug Administration, at the manufacturing plant in DadraUSFDA) one of the warning letter The company’s managing director Dilip Sanghvi was issued a June 18, U.S. Health regulators It was said that it inspected the plant in the Union Territories of Dadra and Nagar Haveli and Daman and Diu from December 4-15, 2023.
“Your company failed to clean, maintain and sanitize and/or sterilize equipment and utensils at appropriate intervals appropriate to the nature of the drug to prevent any spoilage or contamination that could result in any alteration in the safety, identity, strength, quality or purity of the drug product beyond official or other established requirements,” the USFDA said.
The warning letter summarizes the significant violations Current Good Manufacturing Practice It said that CGMP regulations will be implemented for pharmaceuticals manufactured at the plant.
The USFDA further said that the company’s investigation into out-of-specification (OOS) results was inadequate as it lacked scientific rationale to determine root cause.
It said, “Your Company has failed to investigate thoroughly any unexplained discrepancy or failure to meet specifications of a batch or any component thereof, whether or not the batch has already been delivered.”
A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.
The USFDA also made a similar statement cGMP violations at other facilities of the company.
“You committed to conducting a comprehensive assessment of your global manufacturing operations across your company’s network to ensure conformity with FDA requirements. Repeated failures at multiple sites demonstrate that management oversight and controls over the manufacturing of drugs are inadequate,” the US health regulator said.
It said the key findings in this paper indicate that the pharmaceutical company does not operate an effective quality system in accordance with CGMP.
“We strongly recommend that your firm hire a consultant to assist you in meeting cGMP requirements,” the USFDA said.
It further states, “FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations have been fully remedied and we have verified your compliance with CGMPs. We may re-inspect to verify that you have completed corrective action for any deviations,” the USFDA said.
The company said that a reply in writing should be given to this office within 15 working days after receiving this letter.
It also asks you to detail what you have done to correct any deviations and prevent their recurrence.
Warning letters issued by the USFDA typically identify violations, such as poor manufacturing practices, problems with claims about what the product can do, or incorrect instructions for use.
The letter also clarifies that the company must fix the issue, and provides guidelines and a timeline for improvement.
The USFDA then conducts an inspection to ensure that the improvements made by the company are sufficient.
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