FDA Warns Wockhardt for Destroying CGMP Documents, Other Violations

Posted 03 January 2017 By Zachary Brennan

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The beleaguered Indian drug manufacturer Wockhardt is in trouble again with the US Food and Drug Administration (FDA), this time for destroying current good manufacturing practice (CGMP) documents, among a list of other major violations.

In late December, FDA sent a warning letter to the company 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 site’s scrap yard awaiting incineration.

The site was banned from shipping products to the US in August.

In addition to the burning of sensitive documents, FDA inspectors observed 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.”

Wockhardt employees also had unofficial notebooks with records of sample preparation for OOS investigations, route-of-synthesis experiments and scale-up data.

“Our investigator found discrepancies between these unofficial notebooks and the official data retained by your quality unit,” FDA said.

This is the latest in a series of failures by Wockhardt to meet the standards of not just FDA but other regulators.

A March 2013 FDA inspection resulted in an import alert for products manufactured at the company's Waluj, Aurangabad facility, then a warning letter and then another warning letter for multiple sites. And the UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a massive recall for products manufactured at the same facility.

The company's CP Pharmaceuticals subsidiary in Wrexham, UK also received a warning letter in November 2016.

FDA Warning Letter Wockhardt, Ltd. 12/23/16

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Categories: Active pharmaceutical ingredients, Drugs, Crisis management, Compliance, Due Diligence, Manufacturing, News, Asia, FDA

Tags: warning letter, Wockhardt, CGMP

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