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 to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. Specifically, you do not have a procedure that describes the process by which suppliers, contractors, or consultants are evaluated and how their approval status is documented. You did not document the results of any evaluation performed by you that qualifies your supplier of absorbable PDO surgical sutures.
Passage 2Failure to adequately ensure that all personnel are trained to adequately perform their assigned responsibilities, and document training, as required by 21 CFR 820.25(b). Specifically,
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 803.17
- 21 CFR 803.17(a)(2)
- 21 CFR 807.81(a)(3)(ii)
- 21 CFR 820.198
- 21 CFR 820.100(a)
- 21 CFR 820.50
- 21 CFR 820.25(b)