The FDA indicates that federal inspectors have identified serious concerns at two manufacturing plants operated by Baxter International, including one where mold was reportedly growing out of control.
In a warning letter issued on May 31, the FDA cited Baxter production facilities in Marion, North Carolina, and Jayuya, Puerto Rico for failing to conform to current good manufacturing procedures. The company has 15 days from the date of the letter to tell the agency how it plans to fix problems at the two plants, or it could face injunctions or seizure of inventory.
According to the letter, Baxter’s North Carolina plant had mold accumulating at sterile fill lines, on HEPA filters and in other locations. The inspectors found that the company has “not identified the root cause that allowed the mold to proliferate to a level of TNTC (Too Numerous to County) in several environmental samples directly over your filling line.”
The letter cites the company for failing to clean, maintain, sanitize and sterilize equipment used in drug production, which could lead to malfunctions or contamination that negatively affect the quality of supposedly sterile drug products. The investigation took place in November 2012, and the letter says that the mold problems were noted in an August 2012 inspection as well.
The plant’s maintenance workers noted the mold on the supposedly clean side of the HEPA filters as far back as July 6, 2010, the inspection found. However, Baxter failed to properly investigate the reports and address the condition. The company did not even inspect the areas further to confirm that there was mold there, the FDA claims.
Since the investigation, Baxter has responded to investigator claims, indicating that it will address the problems. However, the FDA states in the letter that the plans put forward by the company to fix the situation are inadequate.
Leaking Bags at Puerto Rico Plant
At the Puerto Rico facility, FDA inspectors found leaking bags that could have affected 39 lots of finished drug product and after testing the company discarded portions of 25 of those lots. However, it did nothing to address the products (which the FDA does not name in the letter) that had already been distributed that may have been a problem.
FDA inspectors estimate that finished drug products from 27 different lots may have been affected by the leaking bags but were still sold on the market by Baxter.
The inspection also found that the company had generated 20 nonconformance reports or product retention records linked to particulate matter contamination of its Mini Bag Plus and Quads families of products. The reports found contaminants including fibers of paper, cotton, and nylon, PVC particles, cardboard, human skin and hair, polyester, polyethylene, rayon and frangible material inside the products during the manufacturing process.
The letter noted that there were deficiencies at a third production plant as well, but said that Baxter had put forward plans for addressing problems at the unnamed location that appeared to be adequate.