US FDA warns Bayer over quality control at German plant
The US Food and Drug Administration (FDA) has warned drugmaker Bayer over quality control issues at its active pharmaceutical ingredient (API) plant in Bergkamen, Germany.
The US Food and Drug Administration (FDA) has warned drugmaker Bayer over quality control issues at its active pharmaceutical ingredient (API) plant in Bergkamen, Germany.
The FDA said its inspectors had found "significant deviations from US current good manufacturing practices (CGMP) in the manufacture of non-sterile APls" at the facility during a visit in March.
It said some batches of Drospirenone, used in the company's oral contraceptive pills, Yaz and Yasmin, should not have been released for distribution.
The FDA said that until all of its concerns had been corrected, it could recommend withholding approval of any new applications or supplements listings from Bayer. It may also stop drugs made in Germany from being imported into the US.
The FDA said it had also found that Bayer did not establish and follow adequate procedures for cleaning and maintaining equipment.
Although the FDA acknowledged that Bayer had since made some corrections or would soon implement them, it said the company's response did not "adequately address some of the deficiencies" and disagreed with Bayer's "rationale and conclusion".
Bayer said it had not identified any safety or effectiveness problems relating to the ingredients mentioned by the FDA in its warning letter. The company is analysing the letter and has agreed to respond by 21 September.
