Pernix Receives Form 483 for cGMP Violations
Contract manufacturer Pernix Manufacturing received an 11-observation Form 483 for a litany of cGMP violations, including failing to investigate complaints about caterpillars and poppy seeds in vials of finished product.
The company received four serious complaints regarding particulate matter in products, but didn’t thoroughly investigate the incidents, according to the 483, which followed a March 10 to 21, 2014, inspection. The complaints cited lumps and sediments in solution, a caterpillar drawn into a syringe from a vial and poppy seeds and floating debris at the bottom of bottles.
In all four instances, Pernix closed the investigation and determined there was no root cause, saying either that the problem was not due to the manufacturing process or that it did not perform a review of the manufacturing process.
The company’s investigations of adverse event reports also failed to determine root causes and didn’t include corrective and preventive actions. The FDA investigator also cited Pernix for not maintaining trending data on deviations, out-of-specification results, change controls, aborted batches, rejected raw and in-process materials and finished products.
Pernix was purchased by Houston-based Woodfield Pharmaceutical in April 2014, just weeks after the failed inspection. Woodfield did not respond to a request for comment.
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