Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to adequately establish and maintain procedures that include requirements for identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3).
Passage 2Failure to adequately establish and maintain procedures that include requirements for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4).
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 807.81(a)(3)(ii)
- 21 CFR 807.81(b)
- 21 CFR 820.100(a)(3)
- 21 CFR 820.100(a)(4)