www.fdanews.com/articles/192095-connecticut-drugmaker-warned-for-misuse-of-equipment
Connecticut Drugmaker Warned for Misuse of Equipment
July 23, 2019
The FDA issued a warning letter to Ecometics for serious GMP violations at its Norwalk, Conn., facility, including making drugs on equipment used to make toxic non-drug products.
The agency’s investigators found that the firm manufactured an oral antiseptic and other drugs on the same equipment used to make an insect repellant.
“It is unacceptable as a matter of CGMP to continue manufacturing drugs using the same equipment that you use to manufacture toxic products,” the agency said.