FDA warning letter cites Baxter for mold at plant, hair in infusion products

The FDA has sent Baxter International ($BAX) a warning letter laying out problems it found during inspections at a plant in North Carolina as well as at a plant in Jayuya, Puerto Rico. The Puerto Rico plant was cited two years ago in another warning letter. The May 31 letter lays out a number of issues at the plant in Marion, NC, including mold accumulating over filling lines. The letter says Baxter stopped its line and halted release of products but never figured out the root cause that allowed the mold to grow to a level of TNTC (Too Numerous to Count). Among problems uncovered at the Puerto Rico plant, the FDA said the company found issues with leaky bags on 39 lots. Baxter put a hold on 25 of them but had no plan for dealing with the 14 that had already been released into the market. The FDA also said Baxter reported 20 nonconformance reports on liquid products containing everything from skin to human hair to rayon and that there was no indication that its processes were sound enough to prevent the problem on an ongoing basis. The Jayuya plant, which Baxter has been investing in, was cited two years ago in a warning letter for failing to investigate batch failures. Letter | More