FDA slaps Akorn plant with Form 483

Nov 06, 2018

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.

Read the report here

Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.

Comments

No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments