Warning letterPosted June 10, 2025
FDA warning letter to Sprout Pharmaceuticals, Inc.
False & Misleading Claims/Misbranded
FDA posted a warning letter to Sprout Pharmaceuticals, Inc. on June 10, 2025; the letter is dated May 29, 2025. Subject: False & Misleading Claims/Misbranded. Issuing office: The Office of Prescription Drug Promotion (OPDP).
On the record
- Company
- Sprout Pharmaceuticals, Inc.
- Subject
- False & Misleading Claims/Misbranded
- Issuing office
- The Office of Prescription Drug Promotion (OPDP)
- Letter dated
- 2025-05-29
- Posted by FDA
- 2025-06-10
- Source
- FDA warning letters ↗
CFR cited
The record cites 2 sections of 21 CFR Parts 202 and 314.
The full record
An account shows the violations FDA described and each CFR section it cited.
What a warning letter is
A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.
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