Apotex Bangalore Plant Slammed for More Data Manipulation

October 17, 2014

A fresh inspection has resulted in more data manipulation and other quality problems for Apotex’s beleaguered Bangalore, India, plant.

The drugmaker received a Form 483 after a June to July inspection of the facility.

Investigators discovered facility workers retested drug product samples that failed out-of-specification tests or resulted in poor chromatography results. In addition, Apotex did not investigate the undesirable results per the drugmaker’s standard operating procedure, reads the form issued July 1.

Investigators also discovered a number of unofficial and reported results from dissolution analyses during 2012.

The agency also found facility workers change the dates on sample tests. During an examination of an incubation chamber on June 23 investigators found a microbiologist wrote over the dates for a growth promotion plate using a black maker to make it appear that the growth promotion testing was performed June 19-20, reads the form with four observations.

Both Health Canada and the FDA have banned imports produced at the Bangalore plant.
The FDA warned Apotex earlier this year for a January inspection in which investigators discovered the generics drugmaker retested batches until a desired result is achieved.

Apotex said it is implementing training and IT upgrades to address the observations.

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