FDA warns Bayer over German API facility
pharmafile | September 17, 2009 | News story | Manufacturing and Production | Bayer, FDA, reg
The US regulator has sent a warning letter to Bayer indicating it found "significant deviations from US current good manufacturing practices" in an inspection of one of the company's active pharmaceutical ingredient manufacturing facilities.
The plant, located in Bergkamen in Germany, was inspected by the FDA in March, and Bayer provided details of the measures it was taking to bring the plant back into compliance the following month. FDA then sent a warning letter to Bayer in August, posting it on its website earlier this week.
Among the problems uncovered at the plant were deficiencies in laboratory controls which allowed out-of-specification batches of active pharmaceutical ingredient (API) to be released on the basis of averaged analytical test results, and failure by the plant's quality team to review and investigate the offending batches properly. There were also issues with establishing and monitoring procedures for cleaning and maintenance of equipment.
APIs cited in the letter include norethindrone acetate, ethinylestradiol, drospirenone and norethisterone acetate, all of which are active ingredients used in Bayer's contraceptives and other hormonal products, including its big selling Yaz/Yasmin/Yasminelle brands which together added 644 million euros to the company's coffers in the first six months of 2009.
Despite measures taken by Bayer to retrospectively test the batches, the FDA's letter says: "We remain concerned with your released and distributed API batches used in the manufacture of finished products intended for the US market."
The FDA asked Bayer to respond to the letter (dated August 5) within 30 days of receipt, and warns that until the plant is shown to be back in compliance with current good manufacturing practices (cGMP) it may recommend withholding approval of any new applications or supplements listing Bayer as an API manufacturer and block import of material made at the Bergkamen plant into the US.
Bayer said it continues to investigate the FDA's concerns but does not believe any of the products made using the APIs will be compromised in safety or efficacy.
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