Drug manufacturer Baxter Healthcare received a warning letter from the FDA as a result of cGMP violations at two of its facilities and the company’s failure to submit Field Alert Reports to the FDA. According to the letter, one of Baxter’s facilities had significant environmental monitoring issues, including “clumps” of mold in purportedly sterile manufacturing areas. After the FDA cited Baxter in November 2012, the company failed to investigate how the mold condition was allowed to get as bad as it was, including mold levels “Too Numerous To Count” directly over the facility’s fill line.

The warning letter also states that after discovering a defect in bags for injectable drugs, Baxter failed to recall all affected lots. Baxter then received complaints involving the defect for approximately 30 percent of the non-recalled bags. In spite of the known defect and numerous complaints received from customers, Baxter failed to file Field Alert Reports with the FDA to notify the agency of problems affecting product safety. The facility had been cited for a similar notification failure in January 2011.

Read the entire article, “Repeat Offender: Baxter, The FDA And Too Much Mold To Count”