820.60 Identification.

Each manufacturer shall establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mixups.

Interpretation:

Knowing where your products are at all stages is important however sometimes you may have to put in place additional controls to avoid mixup.  For instance product in a sterilization facility will enter non-sterile and leave processed.  A pallet of medical devices can be difficult to distinguish between processed and unprocessed.  It is sometimes important in such circumstances to provide for physical boundaries that ensure product can not inadvertently get mixup.  This also goes for nonconforming product.  Sometimes it is important to isolate nonconforming product or supplies as an additional security measure. 

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Reference: www.FDA.gov

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