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

Source: https://www.keypedia.com/records/warning_letter/commed-inc/a4b45954-8a2f-43c1-a716-58e458977ecb

> FDA WARNING_LETTER for Commed, Inc. on April 02, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Commed, Inc.
- Inspection Date: 2012-04-02
- Product Type: Devices
- Office Name: Seattle District Office
- Summary: 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

## Related Officers

- [District Director](https://www.keypedia.com/people/charles-m-breen/ea1c624f-6943-4e12-b826-4cffbf358220)

Company: https://www.keypedia.com/companies/commed-inc/57d093df-5a6c-402a-a450-06cc967d9c74

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913