- Vietti Acquisitions, LLC
- Issuing Office:
- New Orleans District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
November 3, 2014
WARNING LETTER NO. 2015-NOL-03
UNITED PARCEL SERVICE
Delivery Signature Requested
Frank Schmitt, General Manager of US Operations
Zwanenberg Food Group (USA) Inc.
3640 Muddy Creek Road
Cincinnati, Ohio 45238
Dear Mr. Schmitt:
During July 7 – 10, and 14, 2014, United States Food and Drug Administration (FDA) investigators inspected your low-acid canned food (LACF) manufacturing facility, Vietti Acquisitions, located at 636 Southgate Avenue, Nashville, Tennessee. This inspection found your firm manufactures a variety of LACF products including, but not limited to, hot dog chili sauce and vegetable soup products. The inspection determined you have significant deviations from the Emergency Permit Control regulation, Title 21, Code of Federal Regulations, Part 108 (21 CFR 108), the LACF regulation, Part 113 (21 CFR 113), and the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulation, Part 110 (21 CFR 110).
As a manufacturer of LACF 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 LACF products. These regulations are described in 21 CFR 108, Emergency Permit Control, and 21 CFR 113, Thermally Processed LACF Packaged in Hermetically Sealed Containers. The Emergency Permit Control regulations were issued, in part, pursuant to Section 404 of the Act, Emergency Permit Control [21 United States Code
(USC) 344]. A temporary emergency permit may be required for LACF products whenever a processor has failed to fulfill the requirements of 21 CFR Part 108.35, including registration and filing of process information, and the mandatory requirements in 21 CFR113. In addition, such failure renders your LACF products adulterated within the meaning of Section 402(a)(4) of the Act, [21 USC 342(a)(4)]. Accordingly your LACF hot dog chili sauce and vegetable soup products are adulterated because they 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 LACF regulations through links in FDA’s Internet home page at www.fda.gov.
Our investigators provided you with a Form FDA 483, Inspectional Observations, at the close of the inspection on July 14, 2014. A copy of the Form FDA 483 is enclosed for your reference. Violations revealed during the inspection include, but are not limited to, the following:
- For an intentional change in a previously filed scheduled process, your firm failed to submit to Center For Food Safety and Applied Nutrition, within 30 days after first use, a complete description of the modifications made and utilized and a copy of the file record showing prior substantiation by a qualified scientific authority as to the safety of the changed process, in accordance with the requirements of 21 CFR 108.35(c)(2)(ii). Specifically, your firm’s scheduled process for 15oz cans of hot dog chili sauce in 300x407 sized cans (SID 1998-07-31/011) identifies (b)(4) as the retort type. Your firm processed this product using (b)(4) May 14, 2014 and November 20, 2013. At this time, we have not received any revised scheduled processes to replace your outdated filed scheduled processes. If your firm no longer uses (b)(4) you must submit updated scheduled processes that accurately reflect your processing operation.
- You failed to test the thermometers for accuracy against a known accurate standard thermometer upon installation and at least once a year thereafter, in accordance with 21 CFR 113.40(a)(1). Specifically, your temperature indicating devices, which are used as the reference devices to indicate each retort's processing temperature, were not calibrated upon installation in February 2014. The thermometer used as the standard to verify the accuracy of each retort's mercury in glass thermometer has not been calibrated since July 10, 2012. The mercury in glass thermometer was used as the reference thermometer for the production of hot dog sauce on July 8, 2014, in retort 5.
We acknowledge your firm uses a (b)(4) which has the capability to calculate alternate process times depending on the measured Minimum Initial Temperature (MIT) of the product and each of your filed processes contains a matrix of designated process parameters to be used based on the measured MIT. During the inspection, our investigators observed processing records with operating process times, temperatures and MITs not identified on your filed process matrices. Your firm’s management indicated these process times and temperatures were calculated by your computer-based program based on the different measured MITs.
We agree (b)(4) devices can calculate a new process time based on a different MIT provided the correct heating factors were used in the system’s calculation. Submitting matrices of alternate filed scheduled processes has been an option for allowing for variations in MITs; however, we have concerns about using an infinite number of process times over the course of a production period for the same product. MITs are designed to be minimum values which are consistently met for a particular product using a standard procedure and formulation. Variation in MITs for a specific product/process raises concern as to the cause of the variation and the potential impact on the product’s heating factors. In addition, there is no standardized methodology for measuring a MIT for any given product. Such a procedure would be required and necessary to demonstrate the accuracy of such measurements. Therefore, at this time, we recommend defaulting to the greater process time/temperature parameters on the filed matrix when a MIT is determined to be different than the MITs identified on the filed matrix.
Good Manufacturing Practices Violations
- You failed to thaw frozen raw materials in a manner that prevents them and other ingredients from becoming adulterated, in accordance with 21 CFR 110.80(a)(6).
a. The temperature of the staging cooler, which contained cardboard cases of frozen diced carrots, IQF green beans, green peas, and frozen potatoes was observed on July 7, 2014, to be 53oF. Excessive condensate was observed between the cardboard boxes and outer plastic wrap. Additionally, pooled water was observed on the floor under many pallets.
b. On July 8, 2014, four pallets of frozen green chilies were observed staged in the kitchen area and held at 85oF from approximately 1:15 pm to 4:00 pm on July 8, 2014. The green chilies reportedly remained unrefrigerated until approximately 5:30 am the following day.
- You failed to construct your facility in such a manner as to prevent drip and condensate from contaminating food and food-packaging materials, in accordance with 21 CFR 110.20(b)(4). Specifically, excessive amounts of condensate in the main cooler was observed on July 7, 2014 dripping from the ceiling and walls onto pallets holding cardboard and paper packaged products including paper bags of corn meal, and frozen diced carrots, potatoes, and tomatoes. Additionally, the cooler floor was observed with dirty standing water in several areas. The cooler temperature in the cooler was documented to be above 50oF during four days during May 2014.
- You failed to clean non-food-contact surfaces of equipment frequently, as necessary to protect against contamination of food, in accordance with 21 CFR 110.35(d)(3). Specifically, the following was observed on July 8, 2014:
a. A water hose, which was secured on the wall, was observed to be hanging down in such a way as to allow the nozzle to touch the floor of the kitchen area.
b. Three large blue plastic barrels, identified as containing vinegar, were observed unlabeled in the kitchen area.
c. Left over chicken noodle soup was observed on the lid of a cooking kettle which contained hot dog chili sauce. The soup was immediately adjacent to an opening leading into the kettle.
d. The grate platform, which the grinder operator stands on when operating the grinder, was observed to have adhering raw chicken from the previous production run.
- You failed to store raw materials in a manner that minimizes deterioration, in accordance with 21 CFR 110.80(a)(1). Specifically, many products, including dumplings were stored in cardboard boxes within your firm's trailer freezer, covered with excessive ice.
- Employees failed to wear appropriate hair restraints in an effective manner, in accordance with 21 CFR 110.10(b)(6). Specifically, on July 8, 2014, the following was observed in the kitchen area during production of hot dog chili sauce:
a. Two employees were observed without proper hair restraints covering their mustaches. One of those employees was observed leaning directly over the processing line during production.
b. One employee was observed without a proper hair restraint covering his beard while working at the grinder until another employee told him to put one on.
c. One employee was observed leaning directly over the processing line while touching and pulling down his beard cover.
You failed to maintain your facility to provide adequate screening or other protection against pest, in accordance with 21 CFR 110.20(b)(7). Specifically, the following gaps and potential pest ingress routes were observed in your facility:
a. A gap of approximately 1/2" between the floor and the left half side of the dock door located in the retort room.
b. At least four holes, each approximately 1" x 1/2", in the broken metal screening of an exhaust fan in the retort room.
The above violations are not intended to be an all-inclusive list of deficiencies at your facility. You are responsible for assuring your processing plant is operating in compliance with the Act, the Emergency Permit Control regulation (21 CFR 108), the Low-Acid Canned Food regulation (21 CFR 113), and the Current Good Manufacturing Practice regulation (21 CFR 110). It is also your responsibility to assure not only the current objectionable conditions are corrected, but appropriate policies and procedures are implemented to prevent recurrence of the problems. You should take prompt action to correct these violations. Failure to make corrections could result in regulatory action without further notice. Possible actions include, but are not limited to, seizure, injunction, and/or the issuance of an order requiring a permit before delivery of introduction or introducing your acidified products into interstate commerce.
You should notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violation, including an explanation of each step taken to prevent the recurrence of a similar violation. You may wish to include in your response documentation that would be useful in assisting us in evaluating your corrections. If you cannot complete all corrective action before you respond, we expect you will explain the reason for your delay and state when you will correct remaining deficiencies.
Your reply should be directed to the U.S. Food and Drug Administration, Attention: Mark W. Rivero, Compliance Officer, at the above address. If you have questions, concerning the contents of this letter, you may contact Mr. Rivero at (504) 832-1290, extension 1103.
Ruth P. Dixon
New Orleans District
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