A flurry of letters promising to do better was not enough to keep the FDA from issuing a warning letter to a German maker of injectable drugs that outlines problems with its sterility procedures.
The letter to Hameln Pharmaceuticals of Hameln, Germany, posted today to the FDA's website, tracks back to inspections done at the company's manufacturing plant in June. Response letters from Hameln to the FDA were sent July 4, Aug. 2, Aug. 31 and Sept. 28, but those explanations did not appease the agency.
Inspectors said they found that employees were not property trained, that one could not "read and accurately record microbial counts," while others in the sterile filling rooms didn't follow procedures for changing gloves as needed, handling dropped objects and taking samples. The agency wasn't satisfied with Hameln simply retraining employees. It said it wanted an explanation about why employees were not properly trained in the first place and what the company intended to do about that problem.
Inspectors also documented problems with the plant's air handling equipment and with its system for monitoring environmental conditions in aseptic processing. Hameln proposed to rebuild restricted access barrier system (RABS) units it said didn't function well wasn't enough. The FDA said the company needed to document what increased risks may have occurred when producing previous batches and tell the agency what it intends to do about them.
The FDA has said it will ramp up inspections of foreign plants this year as it gets additional funds from generic drugmakers under the reauthorization of the FDA user fee law. In testimony to Congress last year, Janet Woodcock, the FDA's director of the Center for Drug Evaluation and Research, pointed out that there are now more foreign drugmakers than U.S. drugmakers for it to inspect.
- read the warning letter