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