FDA Warning letters review 12 octobre 2012

Les mises en demeure récemment publiés par la FDA pointent des écarts déjà signalés dans nos newsletters précédentes et en particulier des manquements dans l'évaluation des fournisseurs pour des fabricants de dispositifs médicaux.

Une première mise en demeure met également en évidence des défaillances dans la validation d'un logiciel utilisé chez un fabricant de dispositif médical et souligne l'absence de documentation descriptive du logiciel, de ses fonctionnalités et de son infrastructure :

3. Failure to validate computer software for its intended use according to an established protocol, when computers or automated data processing systems are used as part of production or a quality system, according to established procedure, as required by 21 C.F.R. 820.70(i). For example, there are no procedures that describe the qualification and maintenance of the Sorting software for decay calculations on brachytherapy seeds sorted into inventory. There are no software verification and validation requirements defined in your firm's procedures, and there are no records documenting that the Sorting software is fully validated for its intended uses. Your firm updated the Sorting software in May 2009, to address a “glitch” when sorting brachytherapy seeds and their respective activity into properly labeled containers; however, your firm failed to validate the updated software prior to implementation for use. There are no procedures or documents that describe changes and version updates to the Sorting software. There are no documents that define the software’s features and functions, operating environment, or hardware requirements.

7. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 C.F.R. 820.50. Failure to establish and maintain the requirements, including the quality requirements that must be met by suppliers, contractors, and consultants. 21 C.F.R. 820.50(a). For example, your procedure for Purchasing, SOP 06-01, Rev. 3 and Vendor Survey, Form No. 06-01-04, Rev. 1 are inadequate in that they do not require an evaluation and qualification determination of vendors, suppliers, and contract service providers listed on your firm’s Approved Vendors List prior to February 28, 2003. There is no documentation that (b)(4)., the supplier of extruded titanium tubes used in the manufacture of Brachytherapy seeds, was qualified or re‑qualified as a supplier. Your firm has been purchasing extruded titanium tubes from this vendor since prior to 2003. 

Dans une autre mise en demeure :

6.      Failure to adequately evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements and failure to document this evaluation, as required by 21 CFR 820.50(a)(1). For example, your firm’s Purchasing Control Procedure, FMS-2015, requires your firm to document supplier evaluations. It also states that (b)(4) and (b)(4) suppliers are grandfathered, but all new and potentially new suppliers are subject to the evaluation of this procedure. However, your firm failed to document evaluation of suppliers that are not listed as grandfathered, such as (b)(4) and (b)(4), supplier of (b)(4)infusion pumps, as well (b)(4), which is a catheter kit assembler overseeing your firm’s products sterilization.