La FDA pointe des écarts de stock...

Dans cette récente mise en demeure adressée à un fabricant de dispositifs médicaux :

4.    Failure to establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mix-ups, damage, contamination, or other adverse effects pending use or distribution, and to ensure that no obsolete, rejected, or deteriorated product is used or distributed, as required by 21 CFR 820.150(a). 

 

Raw materials in your firm’s warehouse are not stored in a manner that would prevent mix-ups. For example:

 

a.    When warehouse bin locations (b)(4) were reviewed for inventory accuracy, the FDA Investigator observed: 

 

i.    Bin (b)(4) contained (b)(4) cases of Cushion 4 (Part 838-222, Lot I15N4) which were not listed on your Physical lnventory Count Sheets. Also, the count sheet indicated Bin (b)(4) contained (b)(4) units of Crown 3 (Part 836-028, Lot I1CDC) however; this component was not present in the bin.

 

ii.    Bin (b)(4) contained (b)(4) cases of Crown 3 (Part 836-028, Lot I1CDC) for a total of (b)(4)units however; this part was not listed on the Physical Inventory Count Sheets for this bin.

 

Your firm’s response, dated September 4, 2013, cannot be evaluated as you acknowledge that corrective actions have not been fully implemented. Additionally, your response indicates you anticipate implementing all corrective actions by (b)(4). Your response also states your firm will implement a real-time inventory management system that utilizes bar codes and scanners by (b)(4).