Inspections, Compliance, Enforcement, and Criminal Investigations
Riverfront Egg Robbers Inc. 6/20/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
June 20, 2012
Connie R. Mertens, President
Riverfront Egg Robbers, Inc.
13757 Highway 70 East
Biscoe, Arkansas 72017
Dear Ms. Mertens:
We inspected your seafood processing facility, located at 13757 Highway 70 East, Biscoe, Arkansas, on January 10 through 12, 2012. Based on the inspection findings and your revised HACCP plan submitted in response to the FDA 483 issued at the conclusion of the inspection, 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, (21 CFR 123). 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 sturgeon and paddlefish roe (caviar) are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
In addition, we have reviewed the labels for your sturgeon and paddlefish roe (caviar). Based on our review, we have concluded that your products are in violation of Section 403 of the Act [21 U.S.C. §§ 343] and regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101).
You may find the Act, the seafood HACCP and labeling regulations, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations are 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 revised HACCP plan for sturgeon and paddlefish roe (caviar) provided with your response lists a critical limit that is not adequate to control pathogens, including Clostridium botulinum growth and toxin production. Specifically, at the “Salting” critical control point, your firm lists “finished product has (b)(4) W.P.S’”. FDA recommends that products such as refrigerated roe packed in a reduced oxygen-packaging material achieve a water phase salt of (b)(4), as a secondary barrier in addition to refrigeration, to prevent Clostridium botulinum growth and toxin formation. The limit listed in your plan is suitable for (b)(4) products where multiple inhibiting factors allow a (b)(4).
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s revised HACCP Plan for sturgeon and paddlefish roe provided with your response lists monitoring procedures that are not adequate to control the hazard of Clostridium botulinum growth and potential toxin formation.
a) at the “Receiving” critical control point, your firm proposes to monitor the conditions of the sturgeon and paddlefish roe by checking the (b)(4) of the (b)(4). In addition to monitoring the (b)(4), you should also be monitoring the adequacy of the ice (b)(4). The (b)(4) should be sufficient to create a (b)(4).
b) at the “Salting” critical control point, your firm proposes to monitor the salinity of the end product roe by using a (b)(4). This equipment has not been recognized by FDA as a reliable method for determining the final water phase salt level of the finished sturgeon and paddlefish roe at this time. Monitoring methods must be suitable for their intended purpose.
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 Food Labeling regulation (21 CFR Part 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
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.
We also have the following comments related to your product labels:
1. Your sturgeon and paddlefish roe (caviar) products do not bear the net quantity of contents as required by 21 CFR 101.105.
2. Your sturgeon and paddlefish roe (caviar) products are stored in freezers at your facility and shipped to your customers on frozen gel-packs. However, your labels do not indicate that the products have been frozen, but, rather, bear the statement, “Keep Refrigerated.” If your product is received by your customers in a thawed state, they may not be aware that your product had been previously frozen or may need to remain frozen during storage. We recommend that you review Compliance Policy Guide (CPG) Section 562.450 at: http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074581.htm for more information regarding the need to include terms such as “frozen” as a part of the statement of identity of a food to avoid misrepresentation or provide information needed to assure proper storage.
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, revised labels, 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.
Please send your reply to the Food and Drug Administration, Attention: Seri L. Essary, Compliance Officer, at the above letterhead address. If you have questions regarding any issues in this letter, please contact Ms. Essary at (214)253-5335.
Reynaldo R. Rodriguez, Jr.
Dallas District Director