Impax handed 12-page 483 at reevaluation

Impax Laboratories has been struggling for two years to get its manufacturing practices down at a plant in California where it intends to produce Rytary, an extended-release Parkinson's drug. The struggles persist, the company has confessed. In fact, a reinspection of the plant was a train wreck, with Impax receiving a Form 483 with a dozen observations, three of them repeats.

The problems again put into question when, or if, the FDA might approve Rytary. Impax ($IPXL) informed investors in January that the FDA would not consider approval of the drug until it had signed off on the plant in Hayward, CA. Impax said this week it was unclear what the new issues would mean for that process, but that it still hopes to launch Rytary in 2014.

CEO Larry Hsu, in a call with analysts, said the company was disappointed but that it has a solid quality-improvement program in place and is going in the right direction. He emphasized that many observations stemmed from work it is doing to meet FDA standards. What needs to happen now, Hsu said, is to "accelerate the program and get it done." It is looking to adding consultants to help it do that. Executives warned, however, that the company must be realistic about the amount of work that has to be done. Launches of other products from the Hayward plant may be delayed as a result of the work to be done but not the launch of products manufactured at its other plants.

A heavily redacted copy of the 483, included with its SEC filing, goes on for 12 pages, listing problems inspectors had with the testing and handling of levadopa, the API in Rytary, as well as problems with testing of 17 other products made at the plant. The FDA also noted that Impax has released lots of drugs, even though the company should have known some of its test methods were inadequate. There were also problems with temperature during drying and problems with holding and warehousing of some products. The FDA said Impax was not thoroughly investigating complaints of broken tablets and that its computer systems lacked adequate controls. There were even problems with the basic cleaning of some equipment.

The most recent finding followed a warning letter in May 2011 and then a follow-up inspection in February 2012 that documented a host of problems. Last year, the company said the FDA had found no problems at its Taiwan plant during a "preapproval inspection for Rytary." Hsu made clear in the call Monday that the company cannot just move production of Rytary to Taiwan and then seek approval. Because the drug was developed in Hayward, that plant must pass muster with the FDA for the company to get approval for Rytary.

- read the release 
- the Form 483 can be found here
- here's the warning letter

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