La gestion des versions d'article à réception...

Dans cette récente mise en demeure, la FDA pointe une défaillance dans la gestion des versions d'article à réception :

5.    Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example, you did not implement the Receiving Inspection Systems procedure DIM 1500 (ver. AB valid date 8/11/2011, ver. AC valid date 10/15/2011 and ver. AE valid date 6/27/2012) which require that prints and product specifications must match the revision on the Goods Receipt or Traveler. The Receiving Inspection Systems Procedure (DIM 1500) requires that the revision and all documentation associated with the same lot must match that of the Goods Receipt, that prints and product specifications must match the revision on the Goods Receipt or Traveler, and that Certificates of Conformance (CofC) of the material must include the dash numbers and revision number. Specifically:

a.   Your management reported that Goods Receipt Slip dated (b)(4) ((b)(4)) represents the initial shipment of Paradigm Insulin Infusion Pumps (MMT-7xx & 5xx) (b)(4) Rev. B from component supplier MPROC. The Goods Receipt Slip states that the revision is Rev. A. However, this lot was manufactured after the ECO 36178 with valid date of (b)(4) that indicates that these parts should have been manufactured to Rev. B.