Red Oak Instruments, LLC
6 extracted findings
FDA source excerpt, selected passage
Failure to adequately establish design change procedures as required by 21 CFR 820.30(i).
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
Failure to adequately establish design change procedures as required by 21 CFR 820.30(i).
Source passage selected by the model
02
Failure of design verification to confirm that design output meets design input requirements as required by 21 CFR 820.30(f).
Source passage selected by the model
03
Failure to establish device acceptance procedures as required by 21 CFR 820.80(d).
Source passage selected by the model
04
Failure to maintain device history record procedures as required by 21 CFR 820.184.
Source passage selected by the model
05
Failure to perform quality audits as required by 21 CFR 820.22.
Source passage selected by the model
06
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).
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.
21 CFR 888.124021 CFR 803.17(a)(1)21 CFR 820.30(i)21 CFR 80321 CFR 807.81(a)(3)(ii)21 CFR 886.9(a)21 CFR 807.81(b)21 CFR 803.1721 CFR 803.321 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 820.30(f)21 CFR 820.80(d)21 CFR 820.18421 CFR 820.2221 CFR 820.20(c)