FDA Food Safety Modernization Act

The new FDA legislation is geared toward bringing the Distributors and Manufacturers industries quality control standards to the level that currently exists in the pharmaceutical industry.

According to the new act, Distributors and Manufacturers will be required to keep control of their inventory recalls and know what products were shipped to which clients. Failure to comply with the new standards will result in severe penalties and a complete recall of all shipments for that period.

The following steps should be taken by Distributors and Manufacturers insuring their Computer Systems comply with the New FDA Safety Act Ruling:

  • The computer system should be able to track Lot Control and Shelf Life Date of all products, in both received and outgoing shipments.
  • If a recall ever occurs, the Distributors and Manufacturers should know exactly which customers received products from that lot number.
  • When inventory is received or shipped, the system should be able to determine if a product is beyond the desired threshold for shelf life.
  • Products being shipped should be checked to see if they are outside the customer's threshold for shelf life. If it doesn't meet the threshold shelf life, it shouldn't be shipped.
  • Shipping the product beyond the customer's threshold shelf life will result in returns, double freight bills and an unhappy customer.

Having accurate lot number control for each product will allow easy tracking of where the contaminated product was used and will enable the Distributors and Manufacturers to notify the customer about the recall.

The warehouse staff will know where the unshipped recalled products are located and will be able to pull them off the shelf.

Recalled product reports should be available for the FDA inspector proving the recalled products were returned and unshipped inventory in the warehouse were pulled off the shelves and will be destroyed.

Establishing Warehouse Control

All products received in the warehouse should be barcode labeled. If the received product doesn't have a bar-coded label, the person who receives the inventory prints the bar-coded label off a small barcode printer that is attached to his/her belt and puts the label on the product. The newly received inventory can then be put in a designated location or a random location. By scanning both the bar-coded label on the product and the location, the computer records will be updated.

Ramification of not meeting the FDA Safety Act

With the various issues resulting from imports from various countries across the globe, meeting the FDA Safety requirements becomes more important then ever. A senior partner at an accounting firm that specializes in the food industry informed me that one of his clients companies with a sales volume of 30 million dollars wasn’t able to determine which customers had received the recalled products. The company was forced to bring back 5 million dollars worth of inventory which resulted in severe financial hardship.

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