Sun Pharma pulled up by USFDA for manufacturing issues at Dadra facility

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-07-04T11:30:58+05:30 | Updated On 4 July 2024 11:30 AM IST

Sun Pharma slapped Rs 76 crore fine by customs authorities

Mumbai: Sun Pharma did not sufficiently clean and maintain the equipment used in drug manufacturing at its manufacturing plant in Dadra, according to the US Food and Drug Administration (USFDA).

According to a warning letter sent to the company's Managing Director, Dilip Shanghvi, on June 18, the USFDA conducted an inspection of the facility located in the Union Territory of Dadra and Nagar Haveli and Daman and Diu from December 4-15, 2023.

"Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitise and/or sterilise 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 said.

The warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals at the facility, it stated.

According to PTI, USFDA further noted that the company's investigations of out-of-specification (OOS) results were inadequate because they lacked 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," it 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 company's other facilities.

"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.

Significant findings in this letter demonstrate that the drug firm does not operate an effective quality system in accord with CGMP, it added.

"We strongly recommend that your firm engage a consultant to assist your firm in meeting CGMP requirements," USFDA stated.

It further said, "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 the company receives this letter, respond to this office in writing within 15 working days, it said.

Specify what you have done to address any deviations and to prevent their recurrence, it added.

The warning letter issued by the USFDA usually identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.

The letter also makes clear that the company must correct the problem and provides directions and a timeframe of its plans for correction.

USFDA then checks to ensure that the company's corrections are adequate.

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Source : with inputs

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751