Apotex - Top 12 GMP Violations

Apotex botches batches

Batch rejects were a major topic in a June 25, 2009, FDA warning letter (WL: 320-09-06) to Apotex concerning a manufacturing facility in Etobicoke, Ontario, Canada, following a December 2008 inspection. The issue came to light as a result of a bacteriological contamination incident, for which the company submitted no NDA field alert report.

After looking into the incident, the regulator's concern was Apotex's apparent lack of investigation into batch failures. Inspectors noted that the company had rejected 554 batches of drug products and in-process materials over a two-year period, without keeping records of investigations. "This high number of rejected batches demonstrates a lack of adequate process controls and raises significant concerns regarding the capability and reliability of your processes," the warning letter says.

Investigators also found that the company had manufactured scale-up batches of Hydrochlorothiazide 12.5mg capsules in early 2008. Some batches failed assay after encapsulation in March 2008. The company's investigation into the matter had yet to be completed by the time the warning letter was sent, and the QC unit had yet to identify a root cause.

"When asked by our investigators why the firm had not yet identified the reasons for the assay failures," the warning letter says, "[an associate director] replied that the firm is ‘working on it.'"

Regulators then asked to see a copy of the completed out-of-spec investigations for the batches and a letter confirming that the batches had been destroyed.

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Apotex - Top 12 GMP Violations