The US Food and Drug Administration(USFDA) has issued a warning letter to Wockhardt for violating current good manufacturing practice norms, including its failure to ensure proper clothing for workers at its Ankleshwar plant in Gujarat.
In the letter to Wockhardt Chairman and Group CEO Habil Khorakiwala, the USFDA said inspectors during inspection from December 7 to 15, 2015, found “significant violations” of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals as well as for active pharmaceutical ingredients (API).
USFDA has already banned import of products from the facility into the US market since August 5, 2016. Elaborating on the violations at the plant, USFDA noted that the company failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination.
“Our investigator observed employees working in gowns that had unravelled stitching extending from hoods, zippers, and pants. Your firm approved these gowns for operations…you should have discarded these garments,” it noted.
The other violations include the firm’s failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile.
“Under dynamic conditions, air did not sufficiently sweep across and away from sterile connections, so the sterility of any product processed under these conditions could be compromised,” USFDA said.
Besides, the inspectors identified multiple aseptic technique breaches during aseptic connection of the equipment. “Your equipment design and aseptic processing operator competencies appear to contribute to the lack of unidirectionality,” the health regulator said.
Also, the firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards, USFDA said.
The firm also failed to exercise appropriate control over computer or related systems to assure that only authorized personnel institute changes in master production and control records.
Commenting on the API production issues, USFDA said the company failed “to record activities at the time they are performed, and destruction of original records”. Besides, the quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs manufactured at the plant, it said.
Until the company corrects all violations and deviations completely and the USFDA confirms its compliance with CGMP, it may withhold approval of any new applications, it said.
“Failure to correct these violations and deviations may also result in FDA continuing to refuse admission of articles manufactured at Ankleshwar, Gujarat, into the United States,” it added.
In a filing to the BSE, Wockhardt said it has already initiated required steps to address the concerns raised by the USFDA and is “putting all its efforts to resolve the same.”
Shares of the drug firm were trading 0.50 per cent down at Rs 662.30 apiece on BSE.