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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Criticare Technologies, 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 adequate 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). Specifically, your firm has not adequately controlled and documented the design of your nGenuity devices. For example:

Passage 2

Failure to establish and maintain procedures to control product that does not conform to specified requirements, including procedures to address the identification, documentation, evaluation, segregation, and disposition of nonconforming (NC) product, as required by 21 CFR 820.90(a). For example, six out of six nonconformance reports reviewed during the inspection did not include documented investigations or dispositions, as required by your procedure. These include:

Citations in the original letter

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

  • 21 CFR 820.100(a)
  • 21 CFR 820.30(g)
  • 21 CFR 820.30(a)
  • 21 CFR 820.30(f)
  • 21 CFR 820.50
  • 21 CFR 820.90(a)