Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d).
Passage 2Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a).
Passage 3Failure to ensure that sampling plans are written and based on a valid statistical rationale when used, as required by 820.250(b).
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 820.80(d)
- 21 CFR 820.75(a)