Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm577969.htm
Timestamp: 2019-03-25 20:50:52
Document Index: 128141936

Matched Legal Cases: ['art 108', 'art 113', 'art 110', 'art 110', '§ 342', 'art 108', '§ 344', '§ 321', 'art 113', 'art 108', '§ 379']

Texas Plum Line 9/22/17
2017-DAL-WL-29
Connie J. Bingham, Owner
5060 Helium Road
Dear Ms. Bingham:
Between the dates of June 19, 2017 to June 22, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 5060 Helium Road, Amarillo, Texas 79124; where you manufacture low-acid food products and low water activity controlled products. The inspection revealed serious violations of regulations for Emergency Permit Control, [Title 21, Code of Federal regulations, Part 108 (21 CFR 108)], Part 113, Low-Acid Canned Foods (LACF) regulations (21 CFR 113), and Part 110, Current good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (21 CFR Part 110). Accordingly, we have determined that your LACF products and low water activity products are 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)], in that it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You can find the Act and the LACF regulations through links in FDA’s home page at: http://www.fda.gov.
As a manufacturer of low acid canned food products, you are required to comply with the Act and the federal regulations related to the processing of LACF and current good manufacturing practices. These regulations are described in 21 CFR Part 108, Emergency Permit Control, and 21 CFR 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers. The Emergency Permit Control regulation was issued, in part, pursuant to Section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary Emergency Permit may be required for low-acid canned foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.35, including registration and filing of process information, and the mandatory requirements in 21 CFR 113.
During our inspection, the following deviations were noted:
Emergency Permit Control & LACF
1. Your firm failed to register with the FDA as a commercial processor of low-acid foods. A commercial processor of low-acid foods is required, no later than 10 days after first engaging in the manufacture, processing, and packaging of thermally processed low-acid foods in hermetically sealed containers in any state, as defined in Section 201(a)(1) [21 U.S.C. § 321(a)(1)]of the Act, to register and file a Form FDA 2541 (food canning establishment registration) with the FDA, as required by 21 CFR 108.35(c) (1). However, our inspection indicated that your firm processes the low-acid food, Special Dark Chocolate Cake with Maraschino Cherries, without registering with the FDA. During our inspection, we collected a sample of your Special Dark Chocolate Cake with Maraschino Cherries, which is packaged in hermetically-sealed glass jars. Our laboratory testing revealed that the sample of the cake contained a pH ranging from 6.21 to 6.53 and a water activity ranging from 0.880 to 0.887. This food meets the definition of “low-acid food” in accordance with 21 CFR 113(n), and therefore is subject to 21 CFR Part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers and the Emergency Permit Control regulations (21 CFR Part 108).
In addition, as a commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers you must, no later than 60 days after registration and prior to packaging of a new product, provide FDA information as to the scheduled processes including but not limited to the processing method, type of retort or other thermal processing equipment employed, minimum initial temperatures, times and temperatures of processing, sterilizing value (Fo), or other equivalent scientific evidence of process adequacy, critical control factors affecting heat penetration, and source and date of the establishment of the process, for each such low acid food in each container, size, as required by 21 CFR 108.35(c)(2). Specifically, your firm has failed to file a scheduled process with FDA for your firm’s Special Dark Chocolate Cake with Maraschino Cherries. As stated previously, our laboratory testing revealed this product meets the definition of a low-acid food in accordance with 21 CFR 113.3(n), and therefore is subject to 21 CFR 113 and 21 CFR 108.
These are repeat observations from the Untitled Letter, dated October 24, 2011.
2. Your firm failed to have a scheduled process established by a qualified person who has expert knowledge through appropriate training and experience of thermal processing requirements for low-acid foods in hermetically sealed containers and have adequate facilities for making such determinations as required by 21 CFR 113.83. Your firm manufactures Special dark Chocolate Cake with Maraschino Cherries that contains a pH above 4.6 and a water activity above 0.85 which is sold in a hermetically sealed glass jar and considered shelf stable.
Once your firm has been provided a scheduled process for your product(s), you must maintain processing and production records documenting the critical factors in accordance with 21 CFR 113.100.
3. Your firm failed to mark each hermetically sealed container of low-acid processed food with an identifying code that identifies in code the establishment where packed, the product contained therein, the year packed and the day packed as required by 21 CFR 113.60(c). Specifically, our inspection revealed that the manufacturing code on your firm’s shelf-stable, hermetically sealed Special Dark Chocolate Cake with Maraschino Cherries merely reflects the batch number and an expiration date. This code does not meet the regulatory requirements for product container coding.
4. Your firm failed to monitor the water activity to prevent the growth of undesirable microorganisms, particularly those of public health significance. Specifically, your firm does not monitor the water activity of your shelf stable Wild Plum Apricot Bread and shelf stable Sugar Plum Cake packaged in 16 oz. hermetically sealed glass jars. These products were evaluated by your process authority and were deemed low water activity controlled. Our laboratory testing also revealed that your Wild Plum Apricot Bread contained a water activity of 0.835 to 0.847 and your Sugar Plum Cake contained a water activity of 0.826 to 0.843.
The above list is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment and the products that you manufacture are in compliance with all requirements of the Act and federal regulations. It is your responsibility to review all products that you manufacture and distribute commercially to determine if they are subject to the LACF regulation (21 CFR 113) and Emergency Permit Control regulation (21 CFR 108).
We offer you the following recall procedure comment:
Your firm failed to prepare and maintain current procedures for products under your control that you will ask your distributors to follow, including plans for effecting recalls of any products that may be injurious to health; for identifying, collecting, warehousing, and controlling the product; for determining the effectiveness of such recall; for notifying the FDA of any such recall; and for implementing such recall program, as required by 21 CFR 108.35. Specifically your firm’s recall procedures are inadequate due to not maintaining the required elements as required by 21 CFR 108.35. During the previous inspection, your firm voluntarily initiated a recall due to undeclared milk and wheat in your finished product without having a proper recall procedure.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspection conducted subsequent to an inspection that identifies noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance had been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluation of the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)].
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the steps that you have taken to bring your firm into compliance with the law. Your response should include each step taken to correct the violations and prevent their recurrence. If you cannot complete all corrections within 15 working days, we expect you to explain the reason for your delay and state when any remaining deviations will be corrected.
Texas Plum Line - Close Out Letter 5/3/18