FDA WARNING_LETTER - Stemell Inc - March 08, 2019

FDA WARNING_LETTER for Stemell Inc on March 08, 2019. Product: Biologics. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Stemell Inc on March 08, 2019. Product: Biologics. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 CFR 211.113(b)

21 CFR 211.68(a)

21 CFR 211.42(c)(10)

21 CFR 211.166(a)

21 CFR 1271.10(a)(2)

21 CFR 211.160(b)

21 CFR 211.198(a)

21 CFR 1271.3(f)(1)

21 CFR 1271.10(a)(1)

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Record Information

Company

Stemell Inc

Inspection Date

March 8, 2019

Product Type

Biologics

Office

Office of Biological Products Operations - Division II

People

Karlton T. Watson (Program Division Director)

ID: 77c97d19-c7d4-4671-b1b3-50137a846391

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