Inspections, Compliance, Enforcement, and Criminal Investigations
Vaughan Foods Inc. (Allison's Gourmet Kitchen) 12/28/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
December 28, 2011
UPS OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
Mark E. Vaughan, President
Vaughan Foods, Inc., dba Allison's Gourmet Kitchens
216 NE 12th St., Suite 8
Moore, OK 73160-2530
Dear Mr. Vaughan:
We inspected your seafood processing facility, located at 216 NE 12th St., Suite 8, Moore, Oklahoma, on 7/26/11 - 8/4/11. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for Foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 and 110).In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery 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). Accordingly, your tuna salad and seafood salad products 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 seafood HACCP regulation and the Fish and Fisheries Product Hazards & Controls Guidance through links in FDA's home page at www.FDA.gov.
Your significant violations were as follows:
1. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6 (c) (3). A critical limit is defined in 21 CFR 123.3 (c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plans for tuna salad and seafood salad list a critical limit during the (b)(4) step critical control point that is not adequate to control the food safety hazards of pathogen growth and Clostridium botulinum growth in tuna salad and seafood salad, and for histamine
formation in tuna salad.
Your HACCP plans, titled "HACCP Plan - Seafood Salad" and "HACCP Plan Tuna Salad", list a critical control point of "Mixed Process Area Temperature" for control of pathogen growth, Clostridium botulinum growth, and histamine formation during mixing and packaging. You monitor this CCP by monitoring the Mixing and Packaging Area room temperature, with a critical limit of "No more than (b)(4) cumulative time above (b)(4) per batch".
However, after mixing, your tuna salad and seafood salad products are transferred to as (b)(4) that measure approximately (b)(4) and have a capacity of at least (b)(4) pounds, in which seafood products are held until packaging. Due to the size and volume of these totes, monitoring area or room temperature alone is not sufficient because the temperature in the center of the tote will not be in equilibrium with the room. Consequently FDA recommends that internal product temperature is also monitored. During the inspection we observed production records that list internal tote temperatures of (b)(4)F or higher. For example, various internal product temperatures that were documented include (b)(4)F on 7/21/11; (b)(4)F on 6/20/11; (b)(4)F on 6/21/11; and (b)(4)F on 6/1/11.
We also observed records which reveal that product has been held in these totes for extended time periods. For example, Seafood Salad was held for (b)(4) from (b)(4) for (b)(4) from (b)(4) and for (b)(4) from (b)(4) and again from (b)(4)
In your written response dated August 22, 2011, you stated that you have performed a reassessment and have chosen to base the CCP on internal temperatures with the critical limit, "if internal product temperature exceeds (b)(4) degrees Fahrenheit, the product will be placed on hold and placed into a (b)(4) cooler at (b)(4) degrees or below. The temperature of this product will be monitored (b)(4) and if the temperature has not reached below (b)(4) degrees within (b)(4) hours a deviation will have occurred and corrective and preventative measures will be taken".
You did not include a copy of your revised HACCP plan with your response letter and consequently we are unable, at this time, to evaluate the adequacy of the correction.
However, you state you have based this change according to the new Fish and Fishery Products Hazards and Controls Guidance, Appendix 4 ("The Guidance"). Because you have processing steps that occur between 40°F and 50°F for times that approach the maximum cumulative exposure times listed in Appendix 4 (when you are holding product in totes, as described above), please note that under these circumstances The Guidance also recommends limiting the time product internal temperatures are between 40°F and 50°F for the hazard of pathogen growth. The Guidance also has recommendations for limiting exposure to temperatures above 40°F for the hazard of histamine, and for limiting exposure time to temperatures in this range for control of Clostridium botulinum growth and toxin production.
2. Because you chose to include corrective action plans in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for tuna salad and seafood salad at the Receiving Storage, Mixed Process Area Temperature, and Finished Goods Cooler critical control points, to control the food safety hazards of pathogen growth and Clostridium botulinum growth in tuna salad and seafood salad, and for histamine formation in tuna salad, are not appropriate.
The corrective actions listed in your HACCP plans for tuna salad and seafood salad, are "Move and retain product in (b)(4) cooler, that is (b)(4)F or below, until room temperature is at or below (b)(4)F" at the Mixed Process Area Temperature CCP, and "Hold and retain product, evaluate based on the incident report of total time and temperature exposure", at the Receiving Storage and Finished Goods Cooler CCPs. These corrective actions are inadequate in that they 1) do not address ensuring that the cause of the deviation was corrected, and 2) do not address the length of time product was held above (b)(4)F, because your critical limits and monitoring procedures do not address internal ingredient or finished product temperatures.
You stated in your August 22, 2011, response letter that you now plan to monitor internal temperature as described above. However, you did not explain whether or not you plan to modify your corrective action plan, including ensuring that the cause of the deviation is corrected, and because you did not include copies of your revised HACCP plans, we are unable to determine whether the inadequacy of these corrective actions has been addressed.
3. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110, as evidenced by condensation that was observed dripping from the ceiling and cooling units of your production rooms during production, and a buildup of condensation that was directly above a mixer which was being used to process seafood salad on 7/26/11. Further, during the inspection our investigators observed that up to 95% of the ceiling of one of your production areas was covered with condensation during production.
You stated in your response letter that your personnel have been trained to look for and to document condensation during processing, and to ensure that it is removed. However, this response does not address how you will ensure that any product that may have been affected by the condensation does not enter commerce. Also, your response fails to address how overhead condensation can be safely removed during processing without contaminating food and food-processing equipment in the room.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention Seri L. Essary, Compliance Officer, FDA Dallas District Office, 4040 N. Central Expressway #300, Dallas, TX, 75204. If you have questions regarding any issues in this letter, please contact Ms. Essary at 214-253-5335 or Seri.Essary@fda.hhs.gov.
Reynaldo R. Rodriguez, Jr.
Dallas District Director