US FDA issues warning letter to Wockhardt’s Ankleshwar plant
New Delhi: The US Food and Drug Administration (US FDA) 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 US FDA said inspectors during inspection from 7 to 15 December 2015, found “significant violations” of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals as well as for active pharmaceutical ingredients (API).
US FDA has already banned import of products from the facility into the US market since 5 August 2016. Elaborating on the violations at the plant, US FDA 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,” US FDA 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, US FDA said.
The firm also failed to exercise appropriate control over computer or related systems to assure that only authorised personnel institute changes in master production and control records.
Commenting on the API production issues, US FDA said the company failed “to record activities at the time they are performed, and destruction of original records”.