The letter, disclosed Wednesday, cited Bayer’s failure to properly clean equipment or establish a quality control unit, among other deficiencies. The FDA also claimed Bayer did not improve conditions and establish necessary quality control protocols at the plant after receiving an initial complaint from the agency in January 2017.
Bayer implemented “corrective measures and modernization work” at the drug facility after receiving the November letter and said the issues do not threaten patient safety, according to a statement from Bayer cited by Handelsblatt Global.
Bayer said the corrective measures may cause temporary supply disruptions for some drug products. The drugmaker expects the changes to hurt 2018 earnings.
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