Wockhardt’s Gujarat plant hit with FDA warning letter
pharmafile | January 5, 2017 | News story | Manufacturing and Production | FDA, Wockhardt
Indian pharma and biotech firm Wockhardt has been accused of violating current good manufacturing practice (CGMP) regulations in a letter issued by the US Food and Drug Administration (FDA) following an inspection of its Ankleshwar manufacturing plant in Gujarat, India from 7 to 15 December, 2015.
The violations were noted in relation to the manufacture of active pharmaceutical ingredients (APIs) as well as finished drugs. During the inspection, the firm reportedly failed to set up adequate procedures for the prevention of microbial contamination, while employees were witnessed wearing gowns in various stages of disrepair, posing a significant threat to good and safe practice:
“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,” the letter stated, adding, “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.”
The letter also raised the concern that “equipment design and aseptic processing operator competencies appear to contribute to the lack of unidirectionality.”
The plant is already under a FDA ban preventing the import of its products into the US as of August 2016; the FDA noted that “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.” Wockhardt has stated that it is in the process of addressing the issues outlined.
This is the latest in a string of blows for the company: only weeks ago in November last year the FDA issued a warning to the firm’s Wrexham, UK facility over drug contamination concerns during manufacturing.
Matt Fellows
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