Hemofarm AD, a Serbian drugmaker owned by Stada Arzneimittel AG (SAZ), said it fixed contamination threats in its aseptic production line found by the U.S. Food and Drug Administration, which halted its exports to the U.S.
The Vrsac, Serbia-based drugmaker has suspended production for the U.S. market for “commercial reasons” while it continues to “take all FDA findings very seriously and to do everything to ensure that” their “production meets standards,” it said in a statement posted on its website today. Hemofarm was responding to FDA findings released on July 10 which questioned its ability to detect microbial contamination in its manufacturing.
FDA said the drugmaker lacked “scientifically sound and appropriate specifications, standards, sampling plans, and test procedures” for products. It warned of possible contamination with Burkholderia cepacia, bacteria that can cause pneumonia in patients with weakened immune system.
“Your firm failed to adequately evaluate the impact of the contamination hazards,” FDA said last week.
Hemofarm said it suspended deliveries of vials to European and U.S. markets in the third quarter of 2011 when it sought to upgrade production and the FDA’s visit to its plant in November was part of the program. FDA recommendations were implemented and “no product from the aseptic production line distributed to any market was under the influence of the problem,” Hemofarm said.
FDA also said it will maintain an import alert and refuses admission to products made at the Vrsac plant into the U.S. until manufacturing practices comply with U.S. laws.
The FDA report led to a 1.6 percent fall in Stada shares on July 10. Serbian health authorities found no trace of the bacteria in Hemofarm products, Tanjug newswire reported today, citing Health Minister Zoran Stankovic. He criticized the FDA for causing damage to Hemofarm.
The state-controlled newswire also reported that Serbia’s Medicines and Medical Devices Agency requested “inspection data” from Hemofarm as it wants to conduct its own investigation.
The pharmaceutical company was bought by Stada for 480 million euros ($588 million) in 2006.
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