Velocity Pharma LLC – FDA Warning Letter, Dec 14, 2023

On July 17, 2024, the FDA issued a Warning Letter to Velocity Pharma LLC, following an inspection from November 3 to December 14, 2023. The inspection was prompted by violative conditions found at Kilitch Healthcare India Limited, a contract manufacturing organization (CMO) used by Velocity Pharma.

The FDA found that Velocity Pharma, a distributor of various eye drop brands, received and delivered adulterated drugs into interstate commerce, violating sections 301(a) and 301(c) of the FD&C Act. The adulteration stems from significant Current Good Manufacturing Practice (CGMP) violations at two CMOs: Kilitch Healthcare India Limited and another unnamed CMO. These violations at the CMOs included poor aseptic practices, inadequate media fill programs, fabricated microbiology records, and microbial contamination, rendering the products adulterated under sections 501(a)(2)(A) and 501(a)(2)(B) of the FD&C Act. Both CMOs were placed on Import Alert and issued their own warning letters.

Velocity Pharma failed to have adequate procedures to ensure ophthalmic drug products met quality attributes and lacked sufficient supplier qualification procedures for its CMOs. Additionally, Velocity Pharma's distribution records were deficient, missing critical information like addresses, batch numbers, and quantities. The FDA also noted a significant delay in recall action by Velocity Pharma and Kilitch, leading the FDA to issue