FDA WARNING_LETTER - Skyless LLC - May 16, 2022

FDA WARNING_LETTER for Skyless LLC on May 16, 2022. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Skyless LLC on May 16, 2022. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

FD&C Act 301(d)

21 U.S.C. 321(p)

21 U.S.C. 355h

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

FD&C Act 502(o)

21 U.S.C. 331(a)

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

21 CFR 211

FD&C Act 502(c)

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Record Information

Company

Skyless LLC

Inspection Date

May 16, 2022

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations II

People

ID: c5637ef6-2559-47b4-979e-5f2fd945bd57

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