FDA Warning letter review 26/10/2012
Une nouvelle mise en demeure de l'agence américaine pointe des défaillances dans l'évaluation des fournisseurs et consultants d'une société de dispositif médicaux :
1. Failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, as required by 21 C.F.R. § 820.50. Specifically,
a) Your “Vendor Evaluation and Quality” work instruction, WI-050-0140, dated 08/21/12, does not adequately establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors and consultants. For example, the requirements, including quality requirements, the contract manufacturer of the AC powered hospital beds must meet have not been established.
b) All suppliers, contractors and consultants have not been evaluated on the basis of their ability to meet specified requirements, including quality requirements. For example, your contract manufacturer of the hospital beds has no evaluation documented. Additionally, only 8 of the 226 suppliers on your approved supplier list have been evaluated.
