FDA WARNING_LETTER - Molteno Ophthalmic Ltd - December 02, 2009

FDA WARNING_LETTER for Molteno Ophthalmic Ltd on December 02, 2009. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Molteno Ophthalmic Ltd on December 02, 2009. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.250(a)

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

21 CFR 820.80(c)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.100(a)(1)

21 U.S.C. 381(a)

21 CFR 820.100(a)(2)

21 CFR 803

21 CFR 820.75(a)

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Record Information

Company

Molteno Ophthalmic Ltd

Inspection Date

December 2, 2009

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: c119472e-4c6f-4629-a229-9cba4470eb49

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