Inspections, Compliance, Enforcement, and Criminal Investigations
Hard-E Foods Inc
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Kansas City District|
11630 West 80 Street
Lenexa, Kansas 66214-3340
Telephone: (913) 752-2100
September 7, 2010
RETURN RECEIPT REQUESTED
Ref: KAN 2010-06
Judith K. Rutz, Owner
Hard-E Foods, Inc.
3228 N. Broadway
St. Louis, MO 63147-3515
Dear Ms. Rutz:
On May 4-7, 2010, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 3228 N. Broadway in St. Louis, Missouri. The inspection revealed that you manufacture several varieties of acidified food products at this facility.
As a manufacturer of acidified food products, you are required to comply with the Federal Food, Drug and Cosmetic Act (the Act), and the federal regulations relating to the processing of acidified food products. These regulations are described in Title 21, Code of Federal Regulations Part 108, Emergency Permit Control (21 CFR Part 108), and Part 114, Acidified Foods (21 CFR Part 114). The Emergency Permit Control regulation was issued pursuant to Section 404 of the Act (21 U.S.C. § 344). 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 of 21 CFR Part 114. In addition, based on certain criteria in Part 114, acidified foods may be adulterated within the meaning of Section 402(a)(3) of the Act (21 U.S.C. § 342(a)(3)) in that they have been manufactured under conditions such that they are unfit for food, or within the meaning of Section 402(a)(4) (21 U.S.C. § 342(a)(4)) in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. For your reference, the Act and the Emergency Permit Control and Acidified Food regulations can be located through FDA's homepage at http://www.fda.gov.
During the inspection, our investigators documented deviations from the Act and the above mentioned regulations relating to the processing of the following acidified foods: Pickled Eggs, Garlic Mustard Pickled Eggs, Beet Pickled Eggs, Sweet Pickled Eggs, and Hot Pickled Eggs. These deviations cause your acidified food products to be adulterated and in violation of Section 402(a)(4) of the Act, in that your Pickled Eggs have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act and the Acidified Food regulations on the Internet through links on the FDA's home page at http://www.fda.gov.
The significant deviations we found at your acidified food processing facility are as follows:
1. Your firm has failed to file a scheduled process for each of the acidified foods you manufacture. At this time, there are no acidified food scheduled processes filed with FDA for any of your Firm's pickled egg products. As a commercial processor engaged in the thermal processing of acidified foods you must, not later than 60 days after registration and prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including conditions for heat processing and control of pH, salt, sugar, and preservative levels, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2).
Scheduled process information for acidified foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on registration and filing can be found in the publication "Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods," available at http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLowAcidCannedFoods/default.htm.
In addition, your firm failed to register with the FDA as a commercial processor of acidified foods. A commercial processor of acidified foods is required, not later than 10 days after first engaging in the manufacture, processing, and packing of acidified foods, to register and file a Form FDA 2541 with the FDA, as required by 21 CFR 108.25(c)(1). Our inspection indicates that your firm has been processing acidified foods at your current location for the past five years, and no registration has been filed with the FDA.
2. Your firm failed to establish scheduled processes of your acidified foods by using 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. Specifically, your firm does not have scheduled processes established by an acidified foods expert for the following acidified food products:
a. Pickled Eggs; Net Weight 2.7 oz and Net Weight 12 oz
b. Garlic Mustard Pickled Eggs; Net Weight 2.7 oz and Net Weight 12 oz
c. Beet Pickled Eggs; Net Weight 2.7 oz and Net Weight 12 oz
d. Sweet Pickled Eggs; Net Weight 2.7 oz and Net Weight 12 oz
e. Hot Pickled Eggs; Net Weight 2.7 oz and Net Weight 12 oz
3. Your firm failed to exercise sufficient control, including frequent testing and recording of results, so that the finished equilibrium pH values for acidified foods are not higher than 4.6 as required by 21 CFR 114.80(a)(2). Specifically, your firm does not monitor or record the finished equilibrium pH of any of the acidified egg products you manufacture to ensure that finished product pH does not exceed 4.6.
4. Your firm failed to hold foods which can support the rapid growth of undesirable microorganisms, particularly those of public health significance, in a manner that prevents the food from becoming adulterated within the meaning of the Act as required by 21 CFR 110.80(b)(3). Specifically, you allowed the ingredient of hard cooked eggs in a citric acid solution, which according to their label are to be kept refrigerated, to set for an undetermined amount of time at room temperature as observed by our investigator. In addition, after this incident was brought to the attention of your firm, the product was placed back under refrigeration and was not further evaluated.
The above violations are not intended to be an all-inclusive list of deficiencies in your plant. Other violations can subject your food to legal action. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Emergency Permit Control regulations (21 CFR Part 108), the Acidified Food regulations (21 CFR Part 114), and the Good Manufacturing Practice regulations for food (21 CFR Part 110). It is also your responsibility to assure that all of your products are in compliance with applicable statutes enforced by FDA.
You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure, injunction, and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit. You should notify this office in writing within fifteen (15) working days of receiving this letter of the specific steps you have taken to correct the noted violations. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Please direct your reply to Amy E. Devine, Compliance Officer, at the address listed above.
Kansas City District