- Post Winery, Inc.
- Issuing Office:
- Dallas District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Dallas District Office|
4040 North Central Expressway
Dallas, Texas 75204-3128
March 22, 2016
Matthew J. Post, Owner
Andrew B. Post, President
Post Winery, Inc.
1700 Saint Mary’s Mountain Road
Altus, Arkansas 72821
Dear Messrs. Post:
On December 15 – 18, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your juice manufacturing facility, located at 1700 Saint Mary’s Mountain Road, Altus, Arkansas, and found that you have serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120). This inspection resulted in FDA’s issuance of a Form FDA-483 (FDA-483) Inspectional Observations, at the conclusion of the inspection.
We have received and reviewed your January 13, 2016, and February 3, 2016, responses to the FDA-483. These responses included your proposed corrective actions. However, your responses did not provide evidence to support the proposed corrective actions, such as a revised and validated HACCP plan, and we are, therefore, unable to evaluate the corrective actions.
In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of 21 CFR 120, renders the juice products 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)]. Therefore, the muscadine red, muscadine white, and concord grape 100% juices are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the Juice HACCP regulation, and the Juice HACCP Hazards and Controls Guidance through links in FDA’s home page at http://www.fda.gov
During our inspection, we observed the following significant violations:
1. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 120.8(b)(3). However, your firm's HACCP plan for "Bottled Grape Juice" lists a critical limit, "Minimum of (b)(4)" at the "Pasteurize" critical control point that is not adequate to control the E. coli 0157:H7 and Salmonella spp. hazards. Specifically, your critical limit does not include the amount of time the juice should be held at (b)(4) in order to control the microbiological hazards.
Your response to the FDA 483 indicated that you will reevaluate your juice process with the help of a thermal processing authority and redefine your critical limits. You should be aware that if you use a (b)(4) processing step to produce a shelf stable juice, you are not required to include control measures in your HACCP plan for achieving a 5-log pathogen reduction. However, under 21 CFR 120.24(a)(2), you must include a copy of the (b)(4) process in your written hazard analysis and you must establish controls for any other hazards, i.e. chemical and physical.
2. You must take a corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 120.10. However, your firm did not take corrective action to control the E. coli 0157:H7 and Salmonella spp. hazards when your process for red muscadine and white muscadine juice deviated from your critical limit at the "Pasteurize" critical control point. For example:
i. On November 11, 2015, you manufactured (b)(4) cases of post red muscadine juice, and the temperature fell below your critical limit of (b)(4) twice during the (b)(4) pasteurization process. No corrective action was taken when these deviations occurred.
ii. On November 12, 2015, you manufactured (b)(4) cases of post red muscadine juice, and the temperature fell below your critical limit of (b)(4) twice during the (b)(4) pasteurization process. No corrective action was taken when these deviations occurred.
iii. On October 28, 2015, you manufactured (b)(4) cases of post white muscadine juice, and (b)(4) cases of unlabeled white muscadine juice, and the temperature fell below your critical limit of (b)(4) once during the (b)(4) pasteurization process. No corrective action was taken when this deviation occurred.
3. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.7(a)(1) and 120.8(b)(1). Your firm’s HACCP plan for red muscadine, white muscadine and concord grape juices does not list the chemical food safety hazard of sulfites. Because you add sulfites to your juice products, to comply with 21 CFR 120.7(a)(1) and 120.8(b)(1), FDA recommends firms have a hazard analysis and associated HACCP plan with controls for food safety hazards, including chemical hazards such as sulfites, that are reasonably likely to occur.
We acknowledge your response to the FDA 483 which indicated that you will begin reviewing all product labels to ensure the proper declaration of sulfites; however, your response did not specify the evaluation and inclusion of this chemical hazard in your hazard analysis and HACCP plan.
4. You must have sanitation standard operating procedure (SSOP) records that document the monitoring of sanitation conditions and practices during processing, and corrections of conditions and practices, to comply with appropriate provisions in 21 CFR 120.6(c) and 21 CFR 120.12(a)(1). However, your firm did not maintain SSOP records for the following conditions:
- Safety of water that comes into contact with food or food contact surfaces;
- Conditions and cleanliness of food contact surfaces, including utensils, gloves, and other outer garments;
- Prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces;
- Maintenance of hand washing, hand sanitizing, and toilet facilities;
- Protection of food, food packaging material, and food contact surfaces from adulteration from chemical, physical, and biological contaminants;
- Proper labeling, storage, and use of toxic compounds;
- Control of employee health conditions that could result in microbiological contamination of food, food packaging materials, and food contact surfaces; and,
- Exclusion of pests from the food plant.
Additionally, you must have and implement a sanitation standard operating procedure that addresses these sanitation conditions and practices, to comply with 21 CFR 120.6(a).
The above is not intended to be an all-inclusive list of violations in connection with your products. It is your responsibility to ensure that all of your products are in compliance with applicable statutes and regulations enforced by the FDA. You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
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 inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)).
For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
You should notify this office in writing within fifteen (15) business days from your receipt of this letter, of the specific steps you have taken to correct the noted deviations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long-term corrective actions, such as evidence that you are working with a process authority, an updated hazard analysis and a validated HACCP plan. If you cannot complete all corrective actions before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deficiencies.
Your written response should be sent to Jamie M. Bumpas, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Ms. Bumpas at 214-253-5336.
Reynaldo R. Rodriguez, Jr.
Dallas District Director
Close Out Letter