Drugmakers outside the U.S. continue to feel the sting of warning letters as FDA inspections of foreign facilities roll on. The most recent foreign plant to come up short is one in Madrid.
A March inspection of the Jabones Pardo plant there found that the drugmaker was not doing a specific identity test on each incoming lot of components, including salicylic acid APIs. Further, the plant was not determining whether its own products met final specifications, including the identity and strength of each active ingredient, before releasing them to the market.
Inspectors also found that Jabones Pardo plant had released several lots of products, including Le'dermis Skin Solutions Anti-Acne Medicated Cream, without any indication that the quality unit had reviewed and approved batch records to make sure the products met standards. Further, the plant was cited for selling two over-the-counter skin creams that had not been registered or approved.
The FDA is expanding its inspections in other countries, particularly in China, after getting a boost from new user fees that generic drugmakers began paying Oct. 1, 2012, although sequestration has complicated the FDA's fee spending this year. The agency also is looking at other ways to focus its attention on the riskiest areas. It is starting a pilot program that would allow some companies to be pre-certified and so require less oversight, allowing it to expend more resources on potential trouble spots.
- here's the warning letter