Responding to an FDA warning letter and import alert, which bans from the U.S. products made at one of its plants, the Serbian drugmaker Hemofarm claims on its website that it has addressed the problems raised by U.S. regulators. Hemofarm, one of the biggest paramedical companies in Serbia, is owned by Germany's Stada Arzneimittel.
The statement says the company suspended production for the U.S. market for "commercial reasons," but is taking the FDA findings seriously and doing everything to make sure its production meets standards, Bloomberg reports.
The FDA warning letter, sent June 20 but posted on the FDA website July 10, resulted from the manufacturer's inability to monitor data, detect contamination risks and remedy its shortcomings at a plant in Vrsac, Serbia. According to the letter, inspectors found during an inspection last year that Hemofarm's plant used desiccated monitoring plates and failed to implement satisfactory bioburden testing and environmental sampling procedures.
Twice media fill samples were found to be contaminated by Burkholderia cepacia, the FDA found, but employees didn't test further to see if the problem extended to other areas of the aseptic operation. FDA inspectors also noticed employees compromising sanitary practices, like leaning over opened sterile vials, among other violations. The agency found Hemofarm's responses inadequate and said some of the violations were repeat violations from a May 2007 inspection.
In its statement, Hemofarm, which was acquired by Stada in 2006, says it suspended deliveries of vials to European and U.S. markets in the third quarter of 2011 when it started a production upgrade, Bloomberg reports. It says the FDA's visit to its plant in November was in response to that upgrade. It claims that the FDA recommendations were implemented and no products affected by the shortcomings were released.
Serbian health officials apparently conducted their own inquiry, found no bacteria problems and criticized the FDA for causing the company harm, Bloomberg says, citing a Serbian news service. But the FDA warning letter says products from the plant will be refused into the U.S. "until such time as your manufacturing practices are verified to comply with CGMPs."
- read the warning letter
- here's the Bloomberg story