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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

ReNovo, Inc. DBA Provision Device Reprocessing Solutions

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 adequately establish procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). Specifically,

Passage 2

Failure to adequately establish procedures to control environmental conditions, as required by 21 CFR 820.70(c). Specifically,

Citations in the original letter

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

  • 21 CFR 807.81(a)(3)(i)
  • 21 CFR 807.81(b)
  • 21 CFR 820.90(a)
  • 21 CFR 820.70(c)