FDA Cites Wockhardt for Multiple Violations

Jan 03, 2017

RAPS

India's Wockhardt has been warned again by the Food and Drug Administration (FDA), this time for destroying current good manufacturing practice (cGMP) documents, among other major violations.

According to Regulatory Affairs Professionals Society, FDA sent a warning letter in December following an eight-day inspection in 2015 of its Ankleshwar, India-based manufacturing site that uncovered “torn and shredded equipment maintenance documents, raw material labels, and change control work orders” in the company’s scrap yard awaiting incineration. In addition, FDA inspectors saw employees working in gowns that put the site’s drugs at risk of contamination because of “unraveled stitching extending from hoods, zippers and pants.”

The agency also said its inspector “found unreported results, including an out-of-specification (OOS) test result for raw materials. You did not investigate this OOS result or explain why you excluded the failing result from the official record.”

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