FDA WARNING_LETTER - Madison Polymeric Engineering - March 23, 2015

On April 22, 2015, the FDA issued a Warning Letter to Madison Polymeric Engineering following an inspection from March 10-23, 2015. The inspection found the firm, a manufacturer of Class 1 and 2 medical foam and detergent, and a contract manufacturer of EP-4 First Step detergent pouches, was not in conformity with Quality System (QS) regulation (21 CFR Part 820). The devices were deemed adulterated under section 501(h) of the Act.

The FDA reviewed the firm's April 2, 2015, response to the FDA 483, deeming it inadequate. Violations included: 1. Failure to establish and maintain procedures to prevent contamination (21 CFR 820.70(e)), specifically lacking water specifications for the EP-4 First Step Bedside Pre-Clean Kit and proper management of a water filter. The response lacked evidence of interim contamination prevention steps. 2. Failure to identify and implement corrective actions for nonconforming product (21 CFR 820.100(a)(3)), specifically not acting on a February 2015 contamination notification for the EP-4 kit (e.g., no shipping holds or quarantines). The response lacked evidence of corrective actions taken. 3. Failure to ensure equipment meets requirements and is properly maintained (