FDA inspectors cite problems at Impax California plant

A small California drugmaker that in January said it was licensing a migraine drug from AstraZeneca ($AZN) is having manufacturing issues that are causing headaches of their own. 

A return inspection found that Impax Pharmaceuticals ($IPXL) continues testing and manufacturing processes that last year led to an FDA warning letter and a recall. According to the FDA inspection report posted last week on the FDA Freedom of Information Act site, Impax appeared to have reported quality control data that was different from its trial samples taken of the Type 2 diabetes drug Acarbose. The Hayward, CA, manufacturing plant also was conducting "unofficial and undocumented  investigations," to evaluate suspect QC data, according to the FDA. That included looking for product cross-contamination due to "unexpected peaks." While conducting undocumented investigations on one hand, it wasn't even looking into "unexpected manufacturing discrepancies," including critical equipment failures on the other, inspectors noted in the February visits.

Last year's warning letter followed a wholesale-level recall of 5 lots of 200-mg fenofibrate capsules. The recall of the high cholesterol treatment was prompted by the problems inspectors found during their visits. Impax had to temporarily reduce production to make quality assurance changes and it brought in some experts to help with fixes.

In an announcement last year, the company said: "The deviations cited related to sampling and testing of in-process materials and drug products, production record review and our process for investigating the failure of certain manufacturing batches to meet specifications." 

This year, the company doesn't seem to have as much to say. A call to Impax was not returned. According to its website description, the specialty drug manufacturer uses its "controlled-release and other in-house development and formulation expertise" to target generics with "technically challenging drug delivery mechanisms or other niches, which may result in lessened competition." Its branded side specializes in developing central nervous system drugs that are differentiated, modified or controlled-release versions of currently marketed medications.

In January, Impax announced that it was paying AstraZeneca $130 million to license three versions of AstraZeneca's  migraine drug Zomig.

- see the FDA inspection report
- read last year's warning letter

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