Inspections, Compliance, Enforcement, and Criminal Investigations
Mabel's Taste of Home, Inc. 28-Jan-08
Department of Health and Human Services
Public Health Service
Minneapolis District Office
January 28, 2008
RETURN RECEIPT REQUESTED
Refer to MIN 08 - 07
Mabel A. Singer
Mabel’s Taste of Home, Inc.
2111 East Main Avenue
West Fargo, North Dakota 58106
Dear Ms. Singer:
The Food and Drug Administration conducted an inspection of your acidified food manufacturing facility on September 27 to October 2, 2007. We found that you have serious deviations from the Acidified Food regulations (21 CFR Parts 108 and 114). A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements in 21 CFR Part 114. Acidified foods processed in violation of certain requirements in 21 CFR Part 114 are considered to be adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] because they have been prepared, packed, or held under insanitary conditions whereby they have been contaminated with filth or may have become injurious to health. You can find the Act and the Acidified Food regulations through links on the Food and Drug Administration (FDA) home page at http://www.fda.gov.
Acidified foods are low-acid foods to which acid or acid foods are added. They have a water activity greater than 0.85 and a finished equilibrium pH of 4.6 or below (21 CFR 114.3(b)). Your Jalapeño Pickled Quail Eggs, Jalapeño Baby Corn, and Jalapeño Baby Mushrooms products are considered to be acidified foods because the predominant ingredient in each product is a low-acid ingredient (quail eggs, whole baby corn, or mushrooms) which is acidified by the addition of vinegar to the product. The pH values were determined to be below 4.6 and water activities above 0.85 for each product. During the inspection, our investigator documented deviations from the Act and the above-mentioned regulations related to the processing of Jalapeño Pickled Quail Eggs, Jalapeño Baby Corn, and Jalapeño Baby Mushrooms. These deviations cause these acidified food products to be adulterated under section 402(a)(4) of the Act.
The significant deviations are as follows:
1. Your firm failed to register, within 10 days after engaging in the manufacture, processing, and packaging of acidified foods, information with FDA including the name of the establishment, principal place of business, and the location of processing establishment, as required by 21 CFR 108.25(c)(1).
2. Your firm failed to provide, not later than 60 days after registration and before packing any new product, the FDA with information on the scheduled process, including as necessary, conditions for heat processing and control of pH, salt, sugar, and/or preservative levels and source and date of the establishment of the process, for each acidified food in each container size. Scheduled process information for acidified foods must be submitted on Form FDA 2541a (food canning establishment process filing form for all methods except aseptic) as required by 21 CFR 108.25(c)(2).
3. Your firm failed to have a scheduled process established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods, as required by 21 CFR 114.83. Your firm did not provide evidence during the inspection that the scheduled processes for Jalapeño Pickled Quail Eggs, Jalapeño Baby Corn, and Jalapeño Baby Mushrooms have been established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
You received a letter from FDA dated September 30, 2004, addressing your failure to register and file process information as required by 21 CFR Part 114. These deficiencies have not been corrected.
During the inspection of September 2007, you were provided with the FDA Guide to Inspections of Acidified Food Manufacturers, FDA Instructions for Establishment Registration & Filing, including Establishment Registration Form 2541, and Industry Guide for Electronic Filing of Acidified & Low Acid Food Processors. Use these informational guides to assist you in complying with the acidified food regulations.
This letter is not intended to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that your establishment is in compliance with all requirements of the Act and FDA regulations.
Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify and make corrections to ensure that similar violations will not recur. Include in your response any documentation showing the corrective actions taken or proposed to be taken. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be implemented.
We advise you to take prompt measures to correct any deviations, including those identified in this letter. Failure to promptly correct these deviations may result in regulatory actions without further notice, such as seizure, injunction, and/or issuance of an Order of Need to Obtain and Hold a Temporary Emergency Permit.
Your reply should be sent to Judy E. Heisick, Compliance Officer, at the address on the letterhead. Ms. Heisick may be reached at (612) 758-7118.
W. Charles Becoat