Medivance Instruments Ltd.: FDA Warning Letter (Feb 13, 2023)

Selected passages from the FDA letter

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

Passage 1
your firm has made significant changes that include, among other things, the incorporation of a new air regulator and changes to the materials used in the powder tubing/valves.

Passage 2
the Modified Velopex Devices are also adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g).

Passage 3
your firm has not verified or validated design changes during and after your firm’s design and development process prior to implementation. Your firm also stated to FDA that certain design changes for your AquaCare devices, including the Aquacut and AquaCare Single and Twin devices, were validated but not adequately documented.

Passage 4
your firm’s corrective and preventive action (CAPA) procedure does not have a requirement to verify or validate corrective and/or preventive action for every CAPA activity. Upon review of thirty CAPA records from 2019to 2021 (including CAPAs 2019-1 to 2019-5, 2019-7 to 2019-16, 2020-1, 2020-2, and 2021-1 to 2021-13), it was observed that none of these records were evaluated for effectiveness.

Passage 5
forty-eight customer complaints from 2019-2022 were reviewed where no investigation was performed, and a justification was not documented as to why no investigation was performed.

Passage 6
your firm’s device DHRs for your AquaCare device lacks identification labeling as well as a Unique Device Identifier (UDI) or Universal Product Code (UPC) for each device unit.

Passage 7
your firm didn’t submit an MDR for the referenced event.

Passage 8
the procedure does not contain information that would indicate that it is an MDR procedure created in accordance with the requirements of 21 CFR 803.17.

Citations in the original letter

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

21 CFR 803.50(a)
21 CFR 803.17
21 CFR 803
21 CFR 803.3(w)
21 CFR 803.17(a)(1)
21 CFR 803.17(b)
21 CFR 803.50
21 CFR 807.81(a)(3)
21 CFR 807.81(b)
21 CFR 820.30(i)
21 CFR 820.100(a)
21 CFR 820.198(b)
21 CFR 820.184