FDA WARNING_LETTER - Leltek Inc. - March 06, 2025

FDA WARNING_LETTER for Leltek Inc. on March 06, 2025. Product: devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Leltek Inc. on March 06, 2025. Product: devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.17(a)(1)

21 CFR 820.50(a)

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

FD&C Act 501(h)

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

21 CFR 803.17(a)(3)

21 CFR 820.30

21 CFR 820(d)

21 CFR 803.50(a)

21 CFR 803.12(a)

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Record Information

Company

Leltek Inc.

Inspection Date

March 6, 2025

Product Type

devices

Office

Office of Health Technology 8 (Radiological Health)

People

Robert A. Ochs (Office Director)

ID: a2c55ba2-4aa8-4795-9ca6-f81e5c71e354

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