The FDA says the unit of Clorox that manufactures povidone-iodine drug products needs to clean a big mess at a plant in Meriden, Connecticut, which failed to follow steps to insure the sterility of its wound products—products that the FDA also said are “unapproved.”
The agency last week posted a warning letter for the Aplicare plant that followed an inspection that ran from Dec. 15, 2015, to Jan. 15, 2016. The letter said that while the products are advertised as being for the “disinfection of wounds or burns,” or as a “preparation of skin and mucous membranes prior to surgery or injections,” the plant failed to implement adequate microbial controls.
The investigators found that the facility had not validated its sterilization process to ensure it worked. Since 2012, testing has repeatedly found samples of povidone-Iodine solution, swabsticks and sponges that were contaminated with microorganism like bacillus licheniformis, the letter said. It added notes regarding air handling issues and the plant's stability testing.
Finally, the FDA said that some of its products are unapproved because they do not comply with the FDA’s OTC Final Monograph for Topical Antifungal Drug Products. The FDA told Aplicare it would do well to hire a consultant that could help it meet FDA standards and improve processes like its handling of out of specification results.
Iodine product makers have run into regulatory concerns before. In 2015, French inspectors turned up contamination issues at a Chinese plant that manufactured iodine.