FDA WARNING_LETTER - Ultra Seal Corporation - September 14, 2021

FDA WARNING_LETTER for Ultra Seal Corporation on September 14, 2021. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Ultra Seal Corporation on September 14, 2021. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211

21 CFR 211.68(b)

21 CFR 210

21 CFR 211.22(a)

21 CFR 211.192

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

21 CFR 211.160(a)

21 CFR 211.67(b)

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Record Information

Company

Ultra Seal Corporation

Inspection Date

September 14, 2021

Product Type

Drugs

Office

Office of Pharmaceutical Quality Operations

People

ID: 5ebe402b-ba7d-4c9e-a403-8542e6bf2368

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