Mr. Frederick H. Miller
President
LiquidCapsule Manufacturing, LLC
9216 Palm River Road, Suite 203
Tampa , FL 33619-4478
United StatesFEI 3006676534Issued Dec 19, 2025Center for Drug Evaluation and Research (CDER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3006676534.
Violations6
Issue DateDec 19, 2025
Product TypeDrugs
StatusOpen
Letter Details
Firm
LiquidCapsule Manufacturing, LLC
Location
Mr. Frederick H. Miller
President
LiquidCapsule Manufacturing, LLC
9216 Palm River Road, Suite 203
Tampa , FL 33619-4478
United States
FEI Number
3006676534
Country
United States
Issue Date
December 19, 2025
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
LiquidCapsule Manufacturing, LLC, an over-the-counter drug manufacturer in Tampa, Florida, was cited for significant Current Good Manufacturing Practice (CGMP) violations that rendered its drug products adulterated. During a June-July 2025 inspection, the FDA found that the company failed to adequately test incoming components for identity, purity, strength, and quality, and did not validate or establish the reliability of its component suppliers' test analyses at appropriate intervals, as required by 21 CFR 211.84. Notably, the firm failed to perform required USP identity testing on high-risk drug components to detect hazardous impurities and ensure compliance with relevant safety limits.
LiquidCapsule Manufacturing, LLC FDA Warning Letter, December 19, 2025