Impax Brings in Specialists to Fix cGMP Problems

Impax Brings in Specialists to Fix cGMP Problems

May 27th, 2013 // 1:25 pm @

Latest FDA and cGMP Compliance News

Impax Laboratories has been faced with serious cGMP manufacturing trouble that caused FDA to reject its NDA for a new Parkinson’s disease treatment. So, Impax has hired several regulatory consultants to oversee manufacturing improvements at its plant in California.

To improve its quality of operations, Impax brought in Leslie Benet, M.D., and a former chair of the agency’s expert panel in individual bioequivalance. Also brought in were Allen Chao, M.D., and ex-CEO of Watson Pharmaceuticals. Last to be hired was Peter Terreri, CEO of the firm CGM.

The hope for the company is that these experienced professionals will help to bring the Hayward CA manufacturing operation back into FDA compliance.

Impax has a recent history of 483 problems that have been of great concern to the agency. FDA cited Impax in March 2013 for 12 problems, including:

  • Poor validation methods for the NDA for Rytary, which is the new potential treatment for Parkinsons. This rejection caused GSK to terminate the development deal with Impax.
  • Manufacturing process parameters at the facility were not properly validated.
  • Cleaning procedures and quality operations were deficient.
  • Employees were not properly trained and did not have the experience to perform their assigned jobs.

Bryan Reasons, current SVP of Impax, stated earlier this month that Impax had submitted responses to the 483 in March. The firm also has requested a meeting with the agency’s district office staff in San Francisco. This is to ensure that the company’s plans and actions align with the agency’s expectations.

The 483 from March was released recently, soon after the announcement from FDA that the company’s 300 mg dose of Budeprion was not therapeutically equal to the reference listed drug – Wellbutrin XL 300 mg. This forced Impax to do a recall of the drug.

Before the bioequivalance problem, the same Impax plant got a warning letter from FDA in 2012 that had a repeat observation from the inspection in April 2010. As we know from our upcoming Webinar on 483 and warning letter trends, getting a repeat observation from FDA means it is very likely you will get a warning letter.


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