February 16, 2018
By Eric Palmer
The FDA has lowered the boom on a Bayer finished products plant in Germany. The agency says the plant handled its cleanup so poorly that one of its customers had to recall products because of cross-contamination.
The German drugmaker has indicated that work related to the warning letter, which was issued in November but posted by the FDA only Tuesday, is affecting supplies of some of Bayer’s established products, but not products shipped to the United States. That portfolio includes drugs like its high blood pressure med Adalat, its antibiotic Avelox and erectile dysfunction drug Levitra.
In an emailed statement, the company said the financial impact from the citation to its headquarters plant in Leverkusen will be discussed when it gives 2018 guidance and reports 2017 results later this month.
“Due to the ongoing remediation and also modernization measures at the site, we expect temporary supply limitations affecting our mature product portfolio,” it said, while pointing out that it will continue to supply products through its Leverkusen center.
The company said, “Bayer is fully committed to diligently addressing all items raised by the FDA and to continue the implementation of necessary corrective actions.”
The letter, which stemmed from an inspection of the plant the FDA did in January 2017, found a number of issues in addition to the concerns over the way the plant handled cleaning equipment, which the FDA said led to cross-contamination of some tablets produced for a contract customer. It didn’t name the customer, but Iceland-based Alvogen last year recalled Adalat it said was produced by Bayer.
The agency also said the facility had not thoroughly investigated complaints of leaking product bags. It ordered the company to come up with a list of all complaints about leaking bags that had been received since 2014.
It also criticized the way the plant was handling its records, pointing out the quality control unit had not kept all the records it was supposed to, including on personnel training.
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