FDA WARNING_LETTER - Bioptimal International - November 11, 2023

FDA WARNING_LETTER for Bioptimal International on November 11, 2023. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Bioptimal International on November 11, 2023. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.17(a)(1)

21 U.S.C. 360j(g)

21 CFR 820.75

21 U.S.C. 352(t)(2)

21 CFR 803.18(b)(1)(i)

21 CFR 803.17(a)(3)

21 CFR 820.198(d)

21 U.S.C. 351(f)(1)(B)

21 CFR 820.100(a)

21 CFR 803.50(a)(1)

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Record Information

Company

Bioptimal International

Inspection Date

November 11, 2023

Product Type

Devices

Office

Office of Health Technology 2 (Cardiovascular Devices)

People

ID: f57152e2-3529-4781-8043-3ffcdecb6902

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