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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Owens & Minor, Inc. dba American Contract Systems, Inc.

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to establish and maintain procedures for acceptance of incoming product to ensure that incoming product is inspected, tested, or otherwise verified as conforming to specified requirements, and that acceptance or rejection is documented, as required by 21 CFR 820.80(b). For example:

Passage 2

Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 820.80(b)
  • 21 CFR 820.30(a)
  • 21 CFR 820.30(g)
  • 21 CFR 820.30(j)