FDA Hands Akorn 483 Over GMP Issues at New Jersey Site

Regulatory NewsRegulatory News | 05 November 2018 |  By 

In an inspection report released Friday, the US Food and Drug Administration (FDA) details 11 observations from an inspection of Akorn’s Somerset, New Jersey facility in July and August of this year.
This is the second Form 483 Akorn has received in 2018. In May the company was handed a Form 483 listing a total of 13 observations from an inspection of the company’s Decatur, IL facility, the third inspection report issued for that facility in three years.
Form 483
In the 22-page inspection report, FDA lists 11 observations related to Akorn’s quality system, laboratory controls and production processes.
According to FDA, Akorn failed to adequately investigate out-of-specification test results for batches of some of its drugs.
“There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed,” FDA writes.
In one case, FDA says that three batches of the company’s azelastine hydrochloride ophthalmic solution failed stability testing, but the batches “remained in the market until they were recalled during the current inspection.”
In another observation, FDA says the company failed to complete quality related activities within the timeframes established in its procedures, which the agency attributes to “a lack of qualified personnel to complete the work.”
FDA also found that the company did not follow its own stability testing program procedures and that the company did not have appropriate controls on computers and other systems to ensure they are only used by authorized personnel.
Additionally, FDA took issue with some of Akorn’s laboratory records, more than 200 of which the agency says were missing an electronic signature from the appropriate reviewer.
FDA also says that Akorn employees failed to follow procedures meant to prevent microbial contamination of sterile drug products, including in previously recorded video footage that showed “poor aseptic processing techniques.”
In one instance, FDA writes that an “operator was observed to crouch over and use the filling line machine as support to touch and wipe the bottom of [his/her] shoe covered foot and then proceed to touch the filling line machine equipment surfaces without any sanitization in between.”


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