FDA LETTER LIBRARY

FDA application & warning letters

Name: FDA Approval, Complete Response & Warning Letters
Creator: Assyro AI
License: https://www.usa.gov/government-works

Review 1,503 source-backed approval, tentative approval, complete response, and warning letters. Application letters cover 2026; the CRL corpus is complete as published by openFDA, and warning letters cover 2026.

Showing 1297-1308 of 1503 letters

WLWarning Letter
Warning Letter Alan Health Technologies Inc. dba Alan (Feb 20, 2026)
FDA issued a warning letter to Alan Health Technologies Inc. dba Alan concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedFeb 20, 2026
US FDA• False & Misleading Claims/Misbranded (Telehealth)
WLWarning Letter
Warning Letter Refills Health, LLC dba Refills Health (Feb 20, 2026)
FDA issued a warning letter to Refills Health, LLC dba Refills Health concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedFeb 20, 2026
US FDA• False & Misleading Claims/Misbranded (Telehealth)
WLWarning Letter
Warning Letter FitRX, LLC dba FitRx (Feb 20, 2026)
FDA issued a warning letter to FitRX, LLC dba FitRx concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedFeb 20, 2026
US FDA• False & Misleading Claims/Misbranded (Telehealth)
WLWarning Letter
Warning Letter Zeuss LLC dba Zeuss (Feb 20, 2026)
FDA issued a warning letter to Zeuss LLC dba Zeuss concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedFeb 20, 2026
US FDA• False & Misleading Claims/Misbranded (Telehealth)
WLWarning Letter
Warning Letter Strut Health, LLC dba Strut (Feb 20, 2026)
FDA issued a warning letter to Strut Health, LLC dba Strut concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedFeb 20, 2026
US FDA• False & Misleading Claims/Misbranded (Telehealth)
WLWarning Letter
Warning Letter Kare Solutions, LLC dba Zappy (Feb 20, 2026)
FDA issued a warning letter to Kare Solutions, LLC dba Zappy concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedFeb 20, 2026
US FDA• False & Misleading Claims/Misbranded (Telehealth)
WLWarning Letter
Warning Letter Viv Health, Inc. dba VIV RX (Feb 20, 2026)
FDA issued a warning letter to Viv Health, Inc. dba VIV RX concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedFeb 20, 2026
US FDA• False & Misleading Claims/Misbranded (Telehealth)
WLWarning Letter
Warning Letter Good Girl LLC dba GoodGirlRX (Feb 20, 2026)
FDA issued a warning letter to Good Girl LLC dba GoodGirlRX concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedFeb 20, 2026
US FDA• False & Misleading Claims/Misbranded (Telehealth)
WLWarning Letter
Warning Letter Bliv Wellness LLC dba Bliv (Feb 20, 2026)
FDA issued a warning letter to Bliv Wellness LLC dba Bliv concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedFeb 20, 2026
US FDA• False & Misleading Claims/Misbranded (Telehealth)
WLWarning Letter
Warning Letter NewSelf Limited dba NewSelf (Feb 20, 2026)
FDA issued a warning letter to NewSelf Limited dba NewSelf concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedFeb 20, 2026
US FDA• False & Misleading Claims/Misbranded (Telehealth)
WLWarning Letter
Warning Letter 24HrDoc, Inc. dba 24HrDoc (Feb 20, 2026)
FDA issued a warning letter to 24HrDoc, Inc. dba 24HrDoc concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedFeb 20, 2026
US FDA• False & Misleading Claims/Misbranded (Telehealth)
WLWarning Letter
Warning Letter Belle Health LLC dba Belle (Feb 20, 2026)
FDA issued a warning letter to Belle Health LLC dba Belle concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedFeb 20, 2026
US FDA• False & Misleading Claims/Misbranded (Telehealth)

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Warning Letter Alan Health Technologies Inc. dba Alan (Feb 20, 2026)

Warning Letter Refills Health, LLC dba Refills Health (Feb 20, 2026)

Warning Letter FitRX, LLC dba FitRx (Feb 20, 2026)

Warning Letter Zeuss LLC dba Zeuss (Feb 20, 2026)

Warning Letter Strut Health, LLC dba Strut (Feb 20, 2026)

Warning Letter Kare Solutions, LLC dba Zappy (Feb 20, 2026)

Warning Letter Viv Health, Inc. dba VIV RX (Feb 20, 2026)

Warning Letter Good Girl LLC dba GoodGirlRX (Feb 20, 2026)

Warning Letter Bliv Wellness LLC dba Bliv (Feb 20, 2026)

Warning Letter NewSelf Limited dba NewSelf (Feb 20, 2026)

Warning Letter 24HrDoc, Inc. dba 24HrDoc (Feb 20, 2026)

Warning Letter Belle Health LLC dba Belle (Feb 20, 2026)