Inspections, Compliance, Enforcement, and Criminal Investigations
ASK Foods, Inc 28-Mar-06
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REOUESTED
March 28, 2006
Ms. Wendie DiMatteo, Chief Executive Officer and Owner
ASK Foods, Inc.
77 North Hetrick Avenue
Palmyra, PA 17078
Dear Ms. DiMatteo:
On November 3, 7 - 9, 2005, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of your facility, locate at 77 N. Hetrick Avenue, Palmyra, PA. We collected three samples, including ready-to-eat Creamy Dutch Potato Salad and in process cut ingredients, and Amish Potato Salad with Egg. The laboratory analyses, received on November 22, 2005, detected the presence of Listeria monocytogenes (L. monocytogenes) which cause your products to in violation of Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. Section 342(a)(1), in that they bear or contain a poisonous or deleterious substance, which may render the articles of food injurious to health. You may find the Act and the implementing regulations through links in FDA's homepage at www.fda.gov.
Listeria monocytogenes is a pathogenic microorganism, which can cause the serious food-borne bacterial illness known as "listeriosis." Listeriosis can be a serious and sometimes fatal illness for high-risk groups, such as the elderly, newborns, pregnant women and those with weakened immune systems. Food processors and handlers should take all precautions necessary to reduce the risk of contamination and to keep food safe from L. monocytogenes. We strongly recommend you determine the cause(s) of this problem and take corrective action as soon as possible. Strict sanitation measures must be instituted to prevent the presence of this microororganism in your finished product. During the inspection, FDA also observed the following significant deviation from the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110), which causes your ready-to-eat salads to be adulterated within the meaning of Section 402(a)(4) of the Act, 21 U.S.C. Section 342(a)(4):
failure to store raw materials in a manner that protect against contamination [21 CFR 110.80(a)(1). Specifically, during the cleaning and sanitizing operations of the mixer, our Investigator observed aerosolized spray water splash into the vicinity of an uncover container of previously prepared vegetable ingredients.
We may take further action if you do not promptly correct these violations. For instance, we may seize your product and/or enjoin your firm from operating.
We are aware that during the inspection you made a verbal commitment to correct observed deviations, and we received your letter dated December 6, 2005; describing specific corrections you have made. However, your letter does not address the on-going steps you will take to prevent finished products becoming contaminated with pathogenic microorganisms, such as L. monocytogenes. You also indicated in your letter dated December 6, 2005, that your seafood HACCP plan(s) would be reassessed by February 1, 2006. To date, we have not received assessed HACCP plan for seafood products, including ready to eat seafood salads. As a processor of seafood products, you are required to comply with the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR 123. In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).
Please respond in writing within fifteen (15) working days from your receipt of this letter outlining the specific steps you are taking to correct these deviations. Please include in your response documentation, such as your revised HACCP plan(s), copies of sanitation monitoring records, or other useful information to assist us in evaluating your corrections. If you can not complete all corrections before you respond, we expect you to explain the reason for your delay and state when you will correct any remaining deviations.
This letter may not intend to be an all-inclusive list of the deviations at your facility. You are responsible for ensuring your processing plan operates in compliance with the Act, seafood HACCP regulation, and the Current Good Manufacturing Practice regulation for foods (21 CFR 110). You also have a direct responsibility to prevent further violations of the Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Robin M. Rivers, Paralegal Specialist at the address noted in the letterhead. If you have questions regarding any issue in this letter, please contact Ms. Rivers at (215) 717-3076.
Thomas D. Gardine
Philadelphia District Office