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Data integrity and aseptic issues land Wockhardt with FDA warning

Dan Stanton

By Dan Stanton+

04-Jan-2017

Data integrity and aseptic issues land Wockhardt with FDA warning

A Wockhardt facility in India put under import alert last year has received a US FDA warning letter citing issues ranging from data discrepancies to inappropriate aseptic clothing.

The facility in Ankleshwar in the Gujarat region of India which makes finished pharmaceuticals and bulk active pharmaceutical ingredients (APIs) received the US Food and Drug Administration warning letter on December 23, following an inspection in late 2015.

Among the specific violations of cGMP observed, the letter identified the firm’s aseptic processing gowns used to make certain sterile products were inadequate to prevent contamination.

“Our investigator observed employees working in gowns that had unraveled stitching extending from hoods, zippers, and pants,” the Agency wrote. “Five of 10 garments released for use in aseptic production areas had loose fibers or other damage. Per your procedures, you should have discarded these garments.”

Wockhardt also failed to establish and follow written procedures designed to prevent microbiological contamination, failed to ensure laboratory records included complete data derived from all compliance tests, and failed to exercise appropriate controls over computer systems.

Data issues

The FDA also picked the firm up on active pharmaceutical ingredient (API) deviations relating to record keeping and data integrity.

“In your process development laboratory, our investigator found several unofficial notebooks recording sample preparation for OOS investigations, route-of-synthesis experiments, and scale-up data,” the letter said. “Our investigator found discrepancies between these unofficial notebooks and the official data retained by your quality unit.”

It continued: “Our investigator found torn and shredded equipment maintenance documents, raw material labels, and change control work orders in your scrap yard awaiting incineration.”

The letter comes five months after the FDA placed the facility on Import Alert 66-40, banning products made there from being exported to the US.

The site became the third for Wockhardt to be placed under an import alert after its Waluj  and Chikalthana  finished formulation plants – both in Aurangabad, Maharashtra – were hit with US FDA bans in 2013.

At the time of publishing, Wockhardt had not responded to questions about the business impact of the letter or remediation plans at the facility.

However, in the letter the FDA suggests the firm provides a comprehensive investigation into the extent of the inaccuracies in data records and reporting, a risk assessment of the potential effects of the observed failures on the quality of your drugs, and a management strategy for your firm that includes the details of your global corrective action and preventive action plan.

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