MDF Goes Beyond
Complying with FDA Regulations
By
Nov 9, 2005, 09:02

One of our newer clients is a medical equipment company who markets their products to hospitals and medical centers. Their products are not perishable in the ordinary sense, but there is a window of time within which the products perform best. All inventory is First in, First out (FIFO), so that the products move quickly, with minimal chance of exceeding the suggested use date.

All orders are in case lots, and are never broken apart for ordering. The cases have lot or serial numbers on them according to FDA requirements. This information needs to be documented as part of the order process, so that if there is a recall, the lot or serial numbers can be easily traced. MDF installed a hand-held scanner and a computer at one of our packing stations. At the time of shipment, the packers scan the barcode of the serial/lot# of each case, as well as the order number that contains contact information, which is then put into an Excel spreadsheet. This file is sent daily to our client to comply with FDA regulations.


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