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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

W.H.P.M, Inc.

Issued · Posted by FDA

FDA published a close-out letter on Mar 13, 2023. The passages below are from the original warning letter.

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 for identifying product during all stages of receipt, production, distribution, and installation, as required by 21 CFR §820.60.

Passage 2

Failure to adequately maintain quality system records, as required by 21 CFR § 820.186.

Citations in the original letter

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

  • 21 CFR 820.60
  • 21 CFR 820.186