FDA WARNING_LETTER - Tropical Seas, Inc. - May 30, 2018

FDA WARNING_LETTER for Tropical Seas, Inc. on May 30, 2018. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Tropical Seas, Inc. on May 30, 2018. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

FD&C Act 301(d)

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

21 CFR 211.160(b)

21 CFR 201.66

21 CFR 330.1

21 U.S.C. 331(a)

21.U.S.C. 355(a)

21 CFR 211

21 U.S.C. 321(g)(1)(B)

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Record Information

Company

Tropical Seas, Inc.

Inspection Date

May 30, 2018

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations II

People

ID: b9cd279b-b065-4945-8e21-e6a37beb1353

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