A Somerset, New Jersey plant owned by Akorn has been issued a 22-page FDA 483 form detailing 11 observations on its quality system, laboratory controls and production processes. The inspection occurred earlier this year during July and August. This is the second Form 483 the company has received in 2018 as a Dacatur, Illinois facility received 13 observations back in May.
According to the FDA, Akorn did not adequately investigate out-of-specification test results for certain drug batches. The FDA also found plant employees improperly handling data, failed solutions remaining on the market, failures to follow the company's own stability testing procedures and more.
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