FDA Warning Letter issued due to Supplier Qualification

CMO (Contract Manufacturing Organization) supplier qualification and contracts are key focus areas during inspections. The FDA recently issued a Warning Letter to Velocity Pharma LLC, criticizing their supplier qualification and oversight practices. This inspection followed issues at the company's CMO.

The FDA highlighted that Velocity Pharma failed to implement adequate supplier qualification procedures to ensure that drug products from CMOs complied with CGMP regulations. Additionally, the company lacked sufficient procedures to guarantee that all drug products met appropriate quality standards.

Velocity Pharma must now reassess its supplier and CMO qualification program, including establishing a plan for periodic audits. The Warning Letter emphasizes that the company is responsible for drug quality, regardless of agreements with CMOs.