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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Red Oak Instruments, LLC

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 design change procedures as required by 21 CFR 820.30(i).

Passage 2

Failure of design verification to confirm that design output meets design input requirements as required by 21 CFR 820.30(f).

Passage 3

Failure to establish device acceptance procedures as required by 21 CFR 820.80(d).

Passage 4

Failure to maintain device history record procedures as required by 21 CFR 820.184.

Passage 5

Failure to perform quality audits as required by 21 CFR 820.22.

Passage 6

Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency as required by 21 CFR 820.20(c).

Citations in the original letter

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

  • 21 CFR 803.17(a)(1)
  • 21 CFR 803
  • 21 CFR 803.17
  • 21 CFR 803.3
  • 21 CFR 803.50(a)
  • 21 CFR 803.17(a)(2)
  • 21 CFR 803.17(a)(3)
  • 21 CFR 803.17(b)
  • 21 CFR 803.18(b)(1)(i)
  • 21 CFR 807.81(a)(3)(ii)
  • 21 CFR 807.81(b)
  • 21 CFR 820.30(i)
  • 21 CFR 820.30(f)
  • 21 CFR 820.80(d)
  • 21 CFR 820.184
  • 21 CFR 820.22
  • 21 CFR 820.20(c)
  • 21 CFR 886.9(a)
  • 21 CFR 888.1240