From the FDA’s point of view, OTC [over the counter, no prescription needed] drugs and weedkiller just don’t mix. That is the message delivered in a newly posted warning letter to an Iowa company that the FDA says hasn’t seemed to learn from past mistakes.
The FDA sent a warning letter late last month to the owner of Continental Manufacturing Chemist after an inspection of a plant in Madrid, Iowa, which among other things, makes earwax drops, oral rinse, and fluoride toothpastes as well as lawn care and other products.
During the April 2017 visit, investigators discovered that the facility wasn’t physically separating the OTC products like the oral rinse from the weedkiller or adhesive remover and didn’t even have quarantine markings to make sure products didn’t get mixed up.
The plant released at least three batches of oral rinse and two batches of fluoride toothpaste without the products being reviewed by the quality unit and did not “thoroughly investigate” most of the product quality discrepancies or customer complaints that were lodged or half of the 16 manufacturing quality discrepancies noted, the letter notes.
The FDA said that the company’s planned responses were not adequate. It also pointed out that a number of the observations had been noted in previous inspections, even though the plant has a consultant advising it about how to meet FDA standards. The agency said it was time for the company management to figure out the shortcomings and get them fixed.
Some of the issues may be addressed with a new $9.2 million, 80,000-square-foot manufacturing plant that the Ames Tribune reported the company intends to build in Huxley, Iowa, about 12 miles from its current home. The Huxley city council approved a $584,000 financial aid package in August to entice Continental to build the plant there instead of accepting an incentive package that would have had it move to a St. Louis, Missouri, suburb. Additionally, the company is slated to get $829,000 in forgivable, interest-free loans and tax credits from the Iowa Economic Development Agency. The company has promised to add 48 new positions to the 50 it currently has at its current facility.
*Original article online at https://www.fiercepharma.com/manufacturing/separate-weed-killer-from-oral-rinse-fda-tells-otc-maker