FDA WARNING_LETTER - Saint Mary's Medical Group, Inc. - October 15, 2014

FDA WARNING_LETTER for Saint Mary's Medical Group, Inc. on October 15, 2014. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Saint Mary's Medical Group, Inc. on October 15, 2014. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 900.12(j)

42 U.S.C. 263b(h)

21 CFR 900.11(a)

42 U.S.C. 263b(b)(1)(A)(iii)

21 CFR 900.12(e)(6)

21 CFR 900.12(a)(4)

21 CFR 900.12(d)(2)

21 CFR 900.12(a)(1)(ii)(B)

21 CFR 900.12(a)(2)(iv)(A)

21 CFR 900.12(c)(1)(iv)

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Record Information

Company

Saint Mary's Medical Group, Inc.

Inspection Date

October 15, 2014

Product Type

Devices

Office

San Francisco District Office

People

ID: 2ffcfba1-68fb-4060-bbb5-1d5d08cf4a3f

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