Spanish API maker has problems with tests, pests and water
The FDA says a drug and API manufacturing facility in Spain was dirty, in disrepair and couldn't guarantee it consistently provided pure water for drug processing.
The warning letter was sent June 20 to Ercros, after inspectors visited its plant last year in Madrid. And the FDA is not pleased. Among other problems, the inspectors say the company did not validate the water system it began using in 2004. For 11 months, before the arrival of inspectors, rather than testing daily, testing was limited to one data point checked each month. The agency wants more details, after the company's promise to do more and improve testing lacked specifics.
The letter also says the company released lots of products, even after some tests were incompliant with standards. Inspectors also found dirt on top of tanks, leaking pipes and areas had not been cleaned for three months. The inside of some equipment had "an inch of a white substance and contained a shallow pool of liquid at the bottom," the letter says.
The agency also says that some of Ercros quality testing was unverified and said the company made changes in some processes, without determining if they might affect drug expirations. Again, the company's responses did not satisfy the agency.
On top of that, the buildings had holes where pests could get in and inspectors found bird feathers and spiders that confirmed their suspicions. The company's indication that it would fix things up didn't contain the kind of details the agency expected.
With about 80% of drug and API products in U.S. now coming from foreign manufacturers, the FDA has been stepping up inspection of foreign drug and API plants. It says that with additional resources from the just-passed user fee law will make more inspections possible. The law also gives it the power to keep foreign products from coming into the U.S. if foreign makers don't agree to be inspected.
- here's the FDA warning letter
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