Galati Cheese Company Ltd. 3/14/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	College Park, MD

March 14, 2011

WARNING LETTER

VIA OVERNIGHT MAIL

Mr. Joe Galati, Owner and President
Galati Cheese Company Ltd.
931 Tecumseh Road West
Windsor, Ontario
Canada N8X2A9

Reference: #163892

Dear Mr. Galati:

On January 10 and 11, 2011, the United States Food and Drug Administration (FDA) conducted an inspection of your cheese manufacturing facility, located at 931 Tecumseh Road West, Windsor, Ontario, Canada. Based on findings during the inspection, we determined that you have a serious violation of the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110), referred to as the CGMP regulation. Based on your failure to comply with the requirements of the CGMP regulation, your cheese products are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)]. You may find the Act and the CGMP regulation through links on FDA's home page at www.fda.gov.

Your significant violation is as follows:

• You failed to store and transport finished food under conditions that will protect the food against physical, chemical, and microbial contamination, as required by 21 CFR 110.93. Specifically, you store finished ready-to-eat ricotta cheese products in plastic pails with pre-drilled orifices that are ragged and not easily cleanable. The ready-to-eat cheese is in direct contact with the plastic pail and the pre-drilled orifices. In your January 31, 2011 response to the observations discussed during the FDA inspection, you state that you will continue to use the pre-drilled plastic pails for cheese production. Your response is not adequate, because the pre-drilled plastic pails cannot be adequately cleaned and therefore do not protect the ready-to-eat cheese against potential contamination. To comply with 21 CFR 110.93, your firm must store and transport the ready-to-eat cheese under conditions that will protect against such contamination. Alternatives, such as properly designed and manufactured cheese molds that are cleanable and intended for draining whey from ricotta cheese, would be considered acceptable under the CGMP regulation.

You should respond to us in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct this violation. If you cannot complete the corrections before the 30 days, you should explain the reason for your delay and state when you will correct any remaining violations.

If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your ricotta cheese products under Section 801(a) of the Act [21 U.S.C. §381(a)], including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. This procedure is generally based on past history or other information, such as an inspection of a facility, indicating that the factory producing the product or the product itself may not be in compliance with FDA's laws and regulations. DWPE information is conveyed in FDA's Import Alerts.

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and the CGMP regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Brandon Bridgman, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD, 20740, U.S.A. If you have any questions regarding this letter, you may contact Mr. Bridgman by phone at (301) 436-2073 or via email at Brandon.Bridgman@fda.hhs.gov.

Sincerely,

/S/
William A. Correll
Acting Director
Office of Compliance
Center for Food Safety and Applied Nutrition
 

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