FDA WARNING_LETTER - B. Jain Pharmaceuticals Private Limited - August 29, 2018

FDA WARNING_LETTER for B. Jain Pharmaceuticals Private Limited on August 29, 2018. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for B. Jain Pharmaceuticals Private Limited on August 29, 2018. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

FD&C Act 501(a)(2)(B)

21 CFR 211.56(a)

21 U.S.C. 331(a)

21 U.S.C. 353(b)(4)

21 CFR 211

21 CFR 211.67(a)

21 U.S.C. 353(b)(1)

21 CFR 210

21 CFR 211.22(a)

21 U.S.C. 353(b)

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Record Information

Company

B. Jain Pharmaceuticals Private Limited

Inspection Date

August 29, 2018

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 6a2758e4-ac2a-4cde-ac49-3d49168a593f

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