The FDA has sent a warning letter to a drugmaker in Spain after finding during an inspection last year that the company was averaging test results to get a passing score.
The letter to Tedec-Meiji Farma in Alcala De Henares, Spain, provides some insight into why the FDA wants more resources so it can beef up its inspections of foreign manufacturers. The FDA estimates that 80% of the ingredients in drugs sold in the U.S., are now made outside the country.
The FDA says that when a lot of tablets on the 24-month stability table was found out of spec, Tedec-Meiji Farma tested another sample four times. The letter says, "Your firm averaged these retest results to obtain a passing result," but never investigated the "root cause" of the problem or checked to see if other batches might have the same issue. The FDA was not satisfied with the company's response that it was changing procedures because it did not adequately explain how.
Additionally, inspectors are concerned that the company is not testing suppliers' ingredients frequently enough to insure that their products meet standards and have other issues with the way the Spanish manufacturer is operating the plant.
The agency's need to do more inspections of foreign operators has become an important factor in the reauthorization of the FDA's funding bill, which is before the Senate now. Branded drugmakers and medical device manufacturers are kicking in additional fees and genericsmakers would have to pay fees for the first time to provide the agency with additional dollars to do more and do it faster.
- here's the warning letter