FDA WARNING_LETTER - Health Pharma USA LLC - June 03, 2019

FDA WARNING_LETTER for Health Pharma USA LLC on June 03, 2019. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Health Pharma USA LLC on June 03, 2019. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

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

21 CFR 211

21 CFR 211.188

21 CFR 210

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

21 CFR 211.22

21 CFR 211.84(d)(1)

21 CFR 211.84(d)(2)

21 CFR 211.34

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Record Information

Company

Health Pharma USA LLC

Inspection Date

June 3, 2019

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations I

People

Diana Amador-Toro (District Director)

ID: c266f585-927f-44ae-8303-d1cca43b446f

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