FDA WARNING_LETTER - Rontis Hellas S.A. - July 25, 2024

FDA WARNING_LETTER for Rontis Hellas S.A. on July 25, 2024. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Rontis Hellas S.A. on July 25, 2024. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.17(a)(1)

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

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

21 CFR 803.17(a)(3)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 803.17(a)(2)

21 CFR 803

21 U.S.C. 351(h)

21 U.S.C. 360i

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Record Information

Company

Rontis Hellas S.A.

Inspection Date

July 25, 2024

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: fb493dba-5c2c-4745-ae9a-566cb82a4711

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