Impax Hit With Another FDA 483

Impax Hit With Another FDA 483

December 27th, 2014 // 4:30 pm @

Impax Laboratories was hit with its second FDA 483  recently on its plant in Hayward CA. This follows an inspection and 483 for its plant in Taiwan earlier this year.

This latest 483 came just a few months after Impax stated that it was confident that its manufacturing processes were good enough to resubmit an NDA for a drug for Parkinson’s disease. The approval for that drug had been delayed due to concerns from FDA about the firm’s cGMP controls.

In the most recent 483, two of the observations were repeats from the first inspection, which is something FDA particularly frowns upon.

In 2013, the company had to let go over 100 employees at the plant in CA because GMP problems there led GSK to abandon a $180 million partnership with Impax.

The Hayward CA 483 stated that the firm had many pyridostigmine tablets that were not in spec. After they ruled out lab errors, the plant failed to determine if there was a problem in the manufacturing of the pills, and released the product.

Also criticized in the FDA report was plant maintenance, which noted that ceiling tiles were sagging, there was a rusty drain and several problems with a walk in chamber that is used for stability studies and storing product.

Repeat 483 violations concerned not having sufficient protections in place to be sure analysts cannot rewrite and/or delete data during an analysis.

This plant in Hayward has been a major problem for Impax in the last few years. cGMP violations led to a warning letter being issued in 2011.

At the Taiwan plant, observations included validation related problems and also problems with testing during the production of Rytary.


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