Velocity Pharma LLC

Warning LetterOpen

Mr. Ankur J. Shah President Velocity Pharma LLC 26 Blueberry Ct. Melville , NY 11747 United States (b)(6), (b)(7)(C)FEI 2000044401Issued Jul 17, 2024Center for Drug Evaluation and Research (CDER)

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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 2000044401.

Violations4

Issue DateJul 17, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: Velocity Pharma LLC
Location: Mr. Ankur J. Shah President Velocity Pharma LLC 26 Blueberry Ct. Melville , NY 11747 United States (b)(6), (b)(7)(C)
FEI Number: 2000044401
Country: United States
Issue Date: July 17, 2024
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Velocity Pharma LLC received a warning for distributing adulterated ophthalmic drugs (eye drops) under brands including Equate, Rite Aid, CVS, and Up&Up that were manufactured by contract manufacturer Kilitch Healthcare India Limited in violation of Current Good Manufacturing Practice regulations. The FDA inspection revealed that Kilitch operated under insanitary conditions with poor aseptic practices for sterile drug manufacturing, causing the finished drug products to become contaminated and potentially injurious to health. Velocity Pharma's receipt and distribution of these adulterated drugs in interstate commerce violated the Federal Food, Drug, and Cosmetic Act.

Velocity Pharma LLC FDA Warning Letter, July 17, 2024