FDA WARNING_LETTER - Grace Analytical Lab Inc - May 30, 2019

FDA WARNING_LETTER for Grace Analytical Lab Inc on May 30, 2019. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Grace Analytical Lab Inc on May 30, 2019. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.160(b)

21 CFR 211

21 CFR 211.68(b)

21 CFR 210

21 CFR 211.165(e)

21 U.S.C. 351(a)(2)(B)

21 CFR 211.194(a)

21 CFR 211.22(d)

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Record Information

Company

Grace Analytical Lab Inc

Inspection Date

May 30, 2019

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations III

People

Art O. Czabaniuk (Program Division Director)

ID: 700b1758-6e9b-41ce-9f35-975c8a048da9

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