- Ipsi Specialty Foods
- Issuing Office:
- Kansas City District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214-1524
Telephone: (913) 495-5100
August 26, 2014
Ref. # CMS 435668
RETURN RECEIPT REQUESTED
Ronald L.Bowers, President
IPSI Specialty Foods, Inc.
7069 S. 108thStreet
La Vista, NE 68128-5703
Dear Mr. Bowers:
During July 10 and 11, 2014, a U.S. Food and Drug Administration (FDA) investigator inspected your firm, located at 7069 S.108th Street, La Vista, Nebraska. Our investigator determined your firm manufactures pickled eggs from chickens. As a manufacturer of acidified foods, 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 (21 CFR 108), Emergency Permit Control and 21 CFR 114, Acidified Foods. The Acidified Food regulations were issued, in part, according to Section 404 of the Act [Title 21, United States Code § 344 (21 USC 344)]. A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.25, which includes
registration and filing of process information, and mandatory portions of 21 CFR
an acidified food may be adulterated within the
meaning of Section 402(a)(3) of the Act [21 USC
342(a)(3)] if it consists, in whole or in part, of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or, within the meaning of Section 402(a)(4) of the Act [21 USC 342(a)(4)], if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or may have been rendered injurious to health. You can find the Act and other relevant regulations through links in FDA's
home page at http://www.fda.gov.
During our inspection, we found deficiencies in your system, which are deviations from the Acidified Food regulations. The FDA investigator provided you with the Form FDA 483 which presents the investigator's observations. Based on the inspection, your significant deviations were as follows:
1. Your firm must register with 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 FDA, as required by 21 CFR 108.25(c)(l). Our inspection indicates that your firm has been processing acidified foods at your current location for up to 35 years, and no registration has been filed with FDA for your acidified product, IPSI Fresh Packed Pickled Eggs.
2. You must 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 your firm's IPSI Fresh Packed Pickled Eggs. As a commercial processor engaged in the processing of acidified foods you must, no later than 60 days after registration and before packing any new product, provide FDA information as to the scheduled processes including, as necessary, 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). You must file scheduled processes with FDA for the acidified foods you manufacture.
Scheduled process information for acidified foods must be submitted on a 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 "Establishment Registration and Process Filing for Acidified and Low-Acid Canned Foods (LACF)" available at: http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/default.htm
3. You must have scheduled processes established by a qualified person who has expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods as required by 21 CFR 114.83. Specifically, you do not have established scheduled processes for your acidified product, IPSI Fresh Packed Pickled Eggs.
4. You must exercise sufficient control, including frequent testing and recording of results, so 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 the acidified products you manufacture to ensure finished product pH does not exceed 4.6.
We also found significant deviations from the applicable requirements of 21CFR Part 110 as follows:
5. You must maintain buildings and physical facilities in repair sufficient to prevent food from becoming adulterated per 21 CFR 110.35(a). However, our investigator observed:
• Rust and peeling paint on the ceiling located in the raw shell egg storage room, (Repeat Deviation)
• Rust on the ceiling around the lights located in the egg cooking room, and
• Loose ceiling tiles located in the egg cooking room and the room containing the 3-compartment sink.
6. Your employees must wash hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated per 21 CFR 110.10(b)(3). However, on July 10, 2014, an employee was observed not washing and sanitizing his hands. The employee was handling cardboard containers then turned to a stainless steel table and opened 32 oz. containers filled with peeled whole cooked eggs. His fingers were touching the inside of the jars containing the peeled whole cooked eggs.
7. Your hand-washing facilities must have running water of a suitable temperature per 21 CFR 110.37(e). However, the hand wash sink located in the processing area does not have hot water.
8. Your employees must wear hair nets where appropriate per 21 CFR 110.10(b)(6). However, on July 10, 2014, our investigator observed a male employee was not wearing a hair restraint and was observed working over and around uncovered peeled whole cooked eggs.
9. You must provide adequate lighting in areas where food is examined, stored, or processed per 21 CFR 110.20(b)(5). However, our investigator observed several burned out ceiling lights throughout the facility to include the processing area.
Within fifteen (15) working days of your receipt of this letter, please notify this office in writing of the current status of your corrective actions and the specific steps that you have taken to correct the noted violations. You should include documentation that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state the time within which you will complete the remaining corrections.
Please send your reply to the Food and Drug Administration, Attention: Jessica E. Hensley, Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 8050 Marshall Dr., Suite 205, Lenexa, Kansas 66214. If you have any questions about this letter, please contact Compliance Officer, Jessica E. Hensley at 913-495-5183.
Cheryl A. Bigham
Kansas City District Office
George Hanssen, Food Safety and Consumer Protection Focus Area Administrator
Nebraska Department of Agriculture
301 Centennial Mall S.
PO Box 95604
Lincoln, NE 68509
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