FDA WARNING_LETTER - Professional Disposables International, Inc. - June 23, 2021

FDA WARNING_LETTER for Professional Disposables International, Inc. on June 23, 2021. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Professional Disposables International, Inc. on June 23, 2021. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 314.81(b)(1)

21 CFR 211

21 U.S.C. 355(k)

21 CFR 210

21 CFR 211.192

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

FD&C Act 505(k)

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Record Information

Company

Professional Disposables International, Inc.

Inspection Date

June 23, 2021

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations I

People

ID: 8825c59a-02af-4b98-9e13-1e8ac8669bdf

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