FDA WARNING_LETTER - Commed, Inc. - April 02, 2012

On March 26 - April 2, 2012, an FDA inspection of Commed, Inc. in Vancouver, Washington, revealed that their tracheostoma covers and stoma screens are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Violations include: 1. Failure to establish and maintain adequate procedures for design change validation, verification, and approval (21 CFR 820.30(i)). For example, a foam change in tracheostoma filters was not verified or validated. 2. Failure to establish and maintain adequate purchasing control procedures and documentation for purchased products and services (21 CFR 820.50). Evaluations of contract manufacturers and suppliers were not maintained. 3. Failure to maintain complaint files and establish adequate complaint handling procedures (21 CFR 820.198(a)). Two telephone complaints regarding tracheostoma filters not sticking were not documented. 4. Failure to establish and maintain adequate procedures for controlling nonconforming product, including documentation of disposition (21 CFR 820.90(a)). Nonconforming products, like holes in filters, were not documented. 5. Failure to establish and maintain adequate procedures for acceptance of incoming product, including documented acceptance/rejection