FDA WARNING_LETTER - Royal Philips - March 13, 2025

FDA WARNING_LETTER for Royal Philips on March 13, 2025. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Royal Philips on March 13, 2025. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 820.160(a)

FD&C Act 501(h)

21 CFR 820.50(a)(1)

21 CFR 803.3

21 CFR 820.100(a)

21 CFR 803.12(a)

FD&C Act 201(h)

21 CFR 820.50(a)(2)

21 CFR 820

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Record Information

Company

Royal Philips

Inspection Date

March 13, 2025

Product Type

Devices

Office

Office of Product Evaluation and Quality

People

Matthew G. Hillebrenner

ID: 3a3f39a4-f2ae-493b-90f3-f78114dd4b33

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