FDA WARNING_LETTER - Eastern Cranial Affiliates, LLC - June 18, 2010

FDA WARNING_LETTER for Eastern Cranial Affiliates, LLC on June 18, 2010. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Eastern Cranial Affiliates, LLC on June 18, 2010. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.70(b)

21 CFR 820.75

21 CFR 820.2S(b)

21 CFR 820.30(a)

21 U.S.C. 360c(i)(1)(A)

21 U.S.C. 352(a)

21 CFR 820.40(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.20(b)

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Record Information

Company

Eastern Cranial Affiliates, LLC

Inspection Date

June 18, 2010

Product Type

Devices

Office

Baltimore District Office

People

Evelyn Bonnin (District Director)

ID: 575081e1-e2ab-4767-889b-f31dc86f0eab

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