US FDA OKs Akorn plant after re-inspection

By Gareth Macdonald contact

- Last updated on GMT


Related tags: U.s. securities and exchange commission, Food and drug administration, Akorn

The US FDA has given Akorn Pharmaceuticals' facility in Decatur, Illinois a clean bill of health after a re-inspection last week. 

Akorn announced the results of the re-inspection in a US Securities and Exchange Commission (SEC) last night​. The firm explained the agency had verified the implementation and effectiveness of its responses to the observations from the June 2016 FDA inspection.

Details of the original inspection of Akorn’s facility in at 1222 W. Grand Ave, Decatur, Illinois were released in October​ when the US regulator published a heavily redacted Form 483​ detailing six observations.

Problems related to documentation, media fill and Akron’s failure to trace the source of foreign matter found in some generic antibiotic drugs made at the site.

A spokeswoman for the firm told us the Form 483 had had "no impact on the manufacturing output​."

Related topics: QA/QC, Regulations

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