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 1,819 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 1597-1608 of 1819 letters

ALApproval Letter
Approval Letter JANSSEN BIOTECH (Feb 20, 2026)
FDA posted an approval letter for RYBREVANT FASPRO on 2026-02-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761484 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 20, 2026
US FDA• RYBREVANT FASPRO
ALApproval Letter
Approval Letter GENERAL AIR SERVICE & SUPPLY COMPANY (Feb 20, 2026)
FDA posted an approval letter for AIR on 2026-02-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221287 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 20, 2026
US FDA• AIR
WLWarning Letter
Warning Letter Genesis Health International Inc. dba Genesis (Feb 20, 2026)
FDA issued a warning letter to Genesis Health International Inc. dba Genesis 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 Peaks Curative, LLC dba Peaks (Feb 20, 2026)
FDA issued a warning letter to Peaks Curative, LLC dba Peaks 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 Join Josie (Feb 20, 2026)
FDA issued a warning letter to Join Josie 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 Kin Meds (Feb 20, 2026)
FDA issued a warning letter to Kin Meds 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 Premium Health Management Inc. dba Premium Health (Feb 20, 2026)
FDA issued a warning letter to Premium Health Management Inc. dba Premium Health 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 Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics (Feb 20, 2026)
FDA issued a warning letter to Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics 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 Levity Inc. dba Levity (Feb 20, 2026)
FDA issued a warning letter to Levity Inc. dba Levity 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 Ivim Services LLC dba Ivim (Feb 20, 2026)
FDA issued a warning letter to Ivim Services LLC dba Ivim 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 PharmaZee (Feb 20, 2026)
FDA issued a warning letter to PharmaZee 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 Weightless Medical LLC dba WeightCare (Feb 20, 2026)
FDA issued a warning letter to Weightless Medical LLC dba WeightCare 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)

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Approval Letter JANSSEN BIOTECH (Feb 20, 2026)

Approval Letter GENERAL AIR SERVICE & SUPPLY COMPANY (Feb 20, 2026)

Warning Letter Genesis Health International Inc. dba Genesis (Feb 20, 2026)

Warning Letter Peaks Curative, LLC dba Peaks (Feb 20, 2026)

Warning Letter Join Josie (Feb 20, 2026)

Warning Letter Kin Meds (Feb 20, 2026)

Warning Letter Premium Health Management Inc. dba Premium Health (Feb 20, 2026)

Warning Letter Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics (Feb 20, 2026)

Warning Letter Levity Inc. dba Levity (Feb 20, 2026)

Warning Letter Ivim Services LLC dba Ivim (Feb 20, 2026)

Warning Letter PharmaZee (Feb 20, 2026)

Warning Letter Weightless Medical LLC dba WeightCare (Feb 20, 2026)