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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Dr. Joel Kaplan Inc.

Issued · Posted by FDA

FDA published a close-out letter on Mar 3, 2026. 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 establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198(a).

Passage 2

Failure to establish and maintain design history files as required by 21 CFR 820.30(j).

Passage 3

Failure to establish and maintain procedures for acceptance activities as required by 21 CFR 820.80(a).

Passage 4

Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements as required by 21 CFR 820.50.

Passage 5

Failure to adequately establish procedures for management review as required by 21 CFR 820.20(c).

Passage 6

Failure to conduct quality audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system as required by 21 CFR 820.22.

Citations in the original letter

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

  • 21 CFR 807.81(b)
  • 21 CFR 807
  • 21 CFR 820.198(a)
  • 21 CFR 820.30(j)
  • 21 CFR 820.80(a)
  • 21 CFR 820.50
  • 21 CFR 820.20(c)
  • 21 CFR 820.22
  • 21 CFR 876.5020
  • 21 CFR 876.5020(b)
  • 21 CFR 884.5970
  • 21 CFR 890.3475
  • 21 CFR 890.5500(b)
  • 21 CFR 890.5500
  • 21 CFR 890.5500(a)
  • 21 CFR 890.9
  • 21 CFR 890.5550
  • 21 CFR 890.3475(b)