FDA WARNING_LETTER - Battelle Memorial Institute - October 07, 2020

FDA WARNING_LETTER for Battelle Memorial Institute on October 07, 2020. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Battelle Memorial Institute on October 07, 2020. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.17(a)(1)

21 CFR 803.20(c)(1)

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

21 CFR 803.20(a)(3)

21 CFR 803.17(a)(3)

21 CFR 803.3

21 CFR 803.50(a)

21 CFR 803.17(a)(2)

21 CFR 803.17(b)

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Record Information

Company

Battelle Memorial Institute

Inspection Date

October 7, 2020

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Binita S. Ashar (Director)

ID: 536ae473-985e-447e-a544-28f9e8413038

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