Smiths Medical ASD Inc.: FDA Warning Letter (Oct 1, 2021)

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1
Failure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).

Passage 2
Failure to establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, including software validation and risk analysis and the results shall be documented in the DHF as required by 21 CFR 820.30(g). Specifically,

Passage 3
Failure to establish procedures for corrective and preventative action, with documentation of activities and results as required by 21 CFR 820.100. Specifically, your CAPA procedure, *Corrective and Preventive Action (CAPA)*, *SOP-20046* has not been adequately established.

Passage 4
Failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as per 21 CFR 820.198(a). Specifically,

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 803.50(a)(2)
21 CFR 803.3
21 CFR 803.17(a)(2)
21 CFR 803.17(a)(3)
21 CFR 803.20(a)(3)
21 CFR 803.17(b)
21 CFR 803.18(b)(1)(i)
21 CFR 803
21 CFR 806.10
21 CFR 820.30(g)
21 CFR 820.100
21 CFR 820.198(a)
21 CFR 820.30(j)
21 CFR 820