Warning Letter: FDA criticises Supplier Qualification

In a recently published Warning Letter, the FDA accuses a pharmaceutical company of hiring an auditor to audit a contract manufacturer, but of having no results or conclusions on the audit.

In addition, the company failed to establish appropriate written responsibilities and procedures for the control of externally produced batches. The company had asked the contract manufacturer to take over manufacturing and packaging activities. The quality agreement stipulated that both sides were responsible for compliance with the relevant cGMP requirements, while the contract manufacturer was solely responsible for the approval or rejection of all products. However, the FDA does not allow the final control and approval to be assigned to an external partner (this would be possible according to EU GMP). It considers the marketing authorisation holder and contract giver to be responsible for the final review and approvals of all batches. This should also be described in the contract.
 
Warehousing has also been assigned. According to the FDA, storing drugs in an external warehouse is a cGMP activity. The selected warehouse, however, had declared that this was "not applicable" and that the employees were not trained in GMP either. According to the FDA, the warehouse should never have been approved and used.

For more details please also see the FDA Warning Letter to Vilvet Pharmaceutical.