Sun Pharma Gets USFDA Warning Letter For Halol Facility, Regulator Warns Action

USFDA on Tuesday notified the pharma major Sun Pharmaceutical in a detailed warning letter about its discrepancies at the Halol facility in Gujarat, which the top US regulator said violates Current Good Manufacturing Practice regulations for finished pharmaceuticals.

In a detailed letter written addressed to Dilip Shanghvi, MD, Sun Pharmaceutical, USFDA said that due to the methods, facilities, or controls for manufacturing, processing, packing, or holding at the facility do not conform to CGMP,  the drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B)

The top US regulator inspected Sun Pharma's Halol facility between April 26 to May 09 in 2022 and found adulterations in drugs. The samples collected for inspection of the drug offered for import in the US and mentioned as (b)(4) capsules in the warning letter failed to meet the specification for dissolution implying that the drug is adulterated, the USFDA said.

"Your (b)(4) capsules, (b)(4) mg, USP are adulterated under section 501(b) of the FD&C Act, 21 U.S.C. 351(b) for failure to conform to compendial standards for strength, quality, or purity," USFDA said in the warning letter.

The regulator further said that Sun Pharma failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes.

"Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accordance with CGMP. In addition to the lack of effective oversight of production operations to ensure reliable facilities and equipment, we found your Quality Unit is insufficiently resourced or enabled with authority to carry out its responsibilities," the regulator stated in the letter.

The FDA stated that Sun Pharma failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas. Whereas it also failed to use equipment in the manufacturing, processing, packing, or holding of drug products that are of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.

Highlighting the faults in internal communications USFDA said that the firm was not able to identify major quality risks due to ineffective internal communication and systems which do not escalate risks to the senior management. The regulator has advised the pharmaceutical company to assess its global manufacturing operations to ensure that systems, processes, and the products manufactured conform to FDA requirements.

The USFDA has also advised Sun Pharma to hire a consultant to help the firm in meeting CGMP requirements. Adding that the consultant does not relieve its obligation to comply with CGMP, and the executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.

USFDA has tasked Sun Pharma to investigate and determine the causes of violations and to prevent any recurrence or the occurrence of other violations. FDA had also placed the facility on Import Alert 66-40 list in early December 2022.

Warning the pharma major for non-compliance the regulator said "FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations".

Failure to address any violations may also result in the FDA refusing admission of articles manufactured at Sun Pharmaceutical Industries Ltd, Halol, into the United States, USFDA added.

The regulator has provided a response time of 15 days for Sun Pharma to reply with the steps taken to address the violations and prevent their recurrence.

The company's stock was trading 1.19 per cent higher on Wednesday at Rs 1023.65 a piece as of 11:40 AM IST.