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Regulatory Procedures Manual March 2009Chapter 7 Recall Procedures Exhibit 74 MODEL RECALL LETTER (GENERIC, ALL CENTERS) COMPANY LETTERHEADURGENT: Insert FOOD, DRUG, MEDICAL DEVICE, BIOLOGIC, COSMETIC,.

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Verify the Defect The first (and perhaps most important) step in any recall is to verify the existence of a defect. For example, perhaps an apparent defect is actually the result of tampering. In that instance, there may be an item-specific problem and no need for a recall.

Submit electronic comments to https://.regulations.gov/. Submit written comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA- 2003-D-0146.

I am pleased to notify you your position of [name of position] is now available, and this is your official recall notice. Please report to work on [date] at [time] and report directly to [name of supervisor or HR department]. Your pay and benefits eligibility will [stay the same or be changed to ______________].

A product recall procedure is a method in which a company retrieves a product from the market and from consumers who purchase it because of a defect or error in its production. During this process, companies compensate or otherwise convince consumers to trade the products in to ensure safety.

Explain how customers or retailers can go about returning the product for a full refund. Include a reproduction of the product's label and a picture of the item itself. Add a telephone number and email and postal addresses where customers can contact your firm about the recall notice.

(DATE, CITY, STATE) -- NAME OF COMPANY today announced a recall of INSERT AMOUNT pounds of TYPE OF PRODUCT, e.g., CHUB-PACKED GROUND BEEF because the product may be contaminated with E. coli O157:H7. The product was sold in a variety of packaging formats to retail stores in INSERT NUMBER states between INSERT DATES.

A recall notice must state the approximate number of product units covered by the recall, including all product units manufactured, imported, and/or distributed in commerce. (2) The type of hazard or risk, including, by way of example only, burn, fall, choking, laceration, entrapment, and/or death.

Your recall plan must include procedures to notify the public about any hazard presented by the food when appropriate to protect public health (See 21 CFR 117.139(b)(2).) For example, public warnings are used to alert the public that a food being recalled presents a serious hazard to health.

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