| Public Health Service Food and Drug Administration |
| Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 334-4100 Fax: (612) 334-4142 |
Department of Health and Human Services
May 9, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED Refer to MIN 11 – 23
Jeffrey A. Zuccaro
President
Zuccaro’s Produce Company
1000 North Third Street
Minneapolis, Minnesota 55401-1019
Dear Mr. Zuccaro:
The Food and Drug Administration (FDA) conducted an inspection of Zuccaro’s Produce Company located at 1000 North Third Street, Minneapolis, Minnesota, on January 31, 2011, and February 1, 4, 2011. The inspection revealed violation of Title 21 of the Code of Federal Regulations, Part 110 (21 CFR Part 110) - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulation which renders your food products 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). Accordingly, your shredded lettuce and frozen foods are adulterated in that they have been prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.
The following violation was observed during the inspection:
1. Your plant and facilities must be constructed in such a way that drip or condensate from fixtures, ducts, and pipes does not contaminate food, food-contact surfaces, or food-packaging materials, to meet the requirements of 21 CFR 110.20(b)(4). However, FDA observed condensate accumulating on the ceiling directly above the area where the shredded lettuce is rinsed in a flume in the fruit and vegetable processing room. The flume is open to the above.
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 all applicable regulations, including the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to prevent further violation of the Act and all applicable regulations. Failure to promptly correct this violation may result in regulatory action without further notice. For instance, we may seize your products and/or enjoin your firm from operating.
In addition, we note that fresh-cut vegetables and fruits have been associated with multiple food borne outbreaks. Processing fresh produce into fresh-cut products such as shredded lettuce increases the risk of bacterial growth and contamination by breaking the natural exterior barrier of the produce and by releasing fluids rich in nutrients. However, fresh-cut produce processors have the capability to reduce the risk of contamination by preparing fresh-cut produce in a controlled, sanitary facility. FDA recommends that you purchase produce grown using Good Agricultural Practices (GAP) and that you process your lettuce in such a way that your finished product does not contain pathogens. Please find additional guidance in “Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables, 2008,” which can be found at http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/produceandplanproducts/ucm064458.htm.
You should notify this office in writing within 15 working days of receipt of this letter of steps you have taken or will take to correct the noted violation and to prevent its recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the correction will be completed.
Your reply should be directed to Compliance Officer Rebecca L. Caulfield at the address indicated on the letterhead.
Sincerely,
/S/
Gerald J. Berg
Director
Minneapolis District
-
No comments:
Post a Comment