Bayer Gets FDA Warning Letter On German PlantSep 16, 2009 | Parker Waichman LLP
Following an inspection in March that caused the U.S. Food and Drug Administration (FDA) concern regarding Bayer AG’s ability to test and monitor quality, a warning was issued to the pharmaceutical giant. Reuters wrote that the issue concerned testing at Bayer’s Bergkamen, Germany facility, citing an FDA letter.
The FDA letter addressed the quality of drug ingredients and testing processes for those pharmaceuticals, said Reuters. "We remain concerned with your released and distributed API batches used in the manufacture of finished products intended for the U.S. market," the FDA wrote in the letter, dated August 5, 2009. API stands for active pharmaceutical ingredients, explained Reuters. The agency also stated that some of Bayer’s, “laboratory controls are deficient.”
In Bayer’s written, April 2009 response, it indicated it was addressing the issues; however, while the FDA acknowledged Bayer’s actions, it said its steps do "not adequately address some of the deficiencies," quoted Reuters.
According to Bayer’s Website, the Bergkamen, Germany site manufactures “ingredients and bulk pharmaceutical chemicals for steroid hormones,” said Reuters.
The Associated Press (AP) explained that the FDA’s warning letter was posted online yesterday. Inspectors said Bayer measured drug ingredient quality utilizing an average of several samples, not reporting on individual test results. Bayer shipped eight batches of pharmaceuticals to the United States tested via the averaging method which is not FDA-acceptable, said the AP. Drug ingredient drospirenone, was involved and which can be found in some birth control drugs, explained the AP, which noted that Bayer markets Yasmin and Yaz, popular birth control pills.
Bayer responded to the FDA, stating that, "the quality of these batches was not affected," quoted the AP. The FDA responded saying that it did not concur with the drug maker’s "rationale and conclusion." In the meantime, said the AP, the agency has requested Bayer send it a complete U.S. shipment list for drugs tested via the averaging method as well as its plans to ensure the issue does not occur again. The FDA may also delay imports from the Bayer plant in the interim.