FDA Warning Letter criticizes Supplier Qualification

CMO Supplier Qualification and the respective contracts in outsourcing activities are always hot topics in inspections. The U.S. Food and Drug Administration (FDA) recently posted a Warning Letter sent to a pharmaceutical company in the US criticizing their supplier qualification and oversight. The inspection was scheduled because of problems at the company's CMO.

For example, the company "failed to have adequate supplier qualification procedures to ensure that the drug products received" from CMOs "were manufactured in compliance with CGMP." They also "failed to have adequate procedures" to ensure tht all drug products produced for the firm met "appropriate quality attributes".

The company now has to evaluate the supplier and CMO qualification program, "including a plan to conduct periodic audits". In the Warning Letter, the FDA clearly points out that the company is responsible for the quality of the drugs "regardless of agreements in place" with CMOs.