Inspections, Compliance, Enforcement, and Criminal Investigations
La Madeleine Gourmet Foods, Inc. 7/17/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204·3128
July 17, 2009
RETURN RECEIPT REQUESTED
Michael R. Shumsky, CEO
La Madeleine Gourmet Foods, Inc.
6688 North Central Expressway, Suite 700
Dallas, Texas 75206
Dear Mr. Shumsky:
We inspected your seafood and acidified soup manufacturing facility, located at 214 South Town East Boulevard, Mesquite, Texas 75149 from March 9-31, 2009. 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 Parts 123 & 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 Clam Chowder Soup and Seafood Bouillabaisse Soup 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 Products Hazards & Controls Guidance: 3rd Edition" (the Hazard Guide) 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 lists the critical control points, to comply with 21 CFR 123.6(c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels."
o However, your firm's HACCP plan for Shellfish Soups (Clam Chowder Soup and Seafood Bouillabaisse Soup) does not list the critical control point of labeling to address the food safety hazard of sulfites. In your response letter dated April 8, 2009, you indicated that your HACCP plan would be revised to include a full Allergen Risk Assessment. Your firm estimated revisions would be completed and approved by May 31, 2009. We have not at this time received any additional correspondence from your firm.
o In addition, your HACCP plan does not include a "cooking" critical control point to control pathogen growth and potential toxin formation, specifically Clostridium botulinum toxin formation. Your letter of response dated April 8, 2009 indicates your HACCP plan will be revised to reflect your current practice of cooking the soup to (b)(4)F to address the Clostridium botulinum hazard. This response also indicates that you intend to cook your Seafood Bouillabaisse Soup for (b)(4) minutes and your Clam Chowder Soup for (b)(4) minutes. Products such as yours, that are packaged in non-flex plastic containers with a film seal having an oxygen transmission rate at (b)(4)F, dry of (b)(4) in 2/day, need to achieve a 6D process to inactivate the nonproteolytic types of Clostridium botulinum. Table #A-4 in the Hazard Guide provides various internal product temperatures coupled with corresponding hold times necessary for achieving this 6D process. According to this table, your firm will need to achieve an "internal product' temperature of 199°F for at least 5 minutes. Consequently, we recommend that you ensure that your soup products consistently achieve this minimum cook of at least 5 minutes at 199°F in the coldest spot of the cooking vat, which is likely the center of the vat. We suggest that you base your cooking time/temperature parameters on a validation study to ensure that you consistently achieve the minimum cook time and temperature at the coldest spot, for each lot of processed soup. FOA recommends the use of equipment capable of continuously monitoring the cook time and temperature for the duration of the cook cycle.
2. 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."
o However, your firm's HACCP plan for Shellfish Soups lists critical limits at the "Chilling Product to (b)(4)F or below" critical control point that are not adequate to control pathogen growth and potential toxin formation, specifically Clostridium botulinum toxin formation. Your plan indicates that product must be chilled to (b)(4)F before packing, however it does not list any corresponding time or temperature limits prior to achieving this final temperature critical limit. For example, the Hazard Guide recommends cooling parameters that achieve a reduction in temperature to 70°F within 2 hours after the cook step and a further reduction in temperature from 70°F to 40°F within an additional 4 hours. Moreover, in addition to monitoring residual chlorine levels in the cooling water as listed in your plan at this critical control point, FDA also recommends monitoring the integrity of the containers to prevent pathogen introduction during the cooling cycle. Your response dated April 8, 2009 does not address cooling of the products.
o In addition, your firm's HACCP plan for Shellfish Soups lists a temperature critical limit at the "Cupping or Bagging" critical control point of (b)(4)F that is inadequate to control recontamination by pathogens. To reduce the likelihood for recontamination of product after cooking, FDA recommends hot filling the product at 185°F.
For more information related to cooling parameters following cooking, please refer to Chapter 16 of the Hazard Guide. For more information related to post-processing contamination, please refer to Chapter 18 of the Hazard Guide.
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for Shellfish Soup does not list monitoring procedures at the "Boxing, Refrigerated Storage, Staging Refrigerated Shipping" critical control point that are adequate to control pathogen growth and potential toxin formation. Specifically, your monitoring procedures for "Boxing, Refrigerated Storage, Staging Refrigerated Shipping," which is your finished product (refrigerated) storage critical control point, are not adequate because they do not include how often temperature monitoring will be performed. The plan lists a monitoring frequency of (b)(4)," while the critical limits reference total exposure time not to exceed (b)(4) hours at temperatures above (b)(4)F. In order to adequately monitor your critical limits of not exceeding (b)(4) hours at temperatures above (b)(4)F, your firm would need the use of equipment capable of continuously monitoring and recording time and temperature 24 hours a day/7 days a week. FDA recommends that firms not only install continuous monitoring equipment on coolers, but also recommends a daily check of both the temperature monitoring record and the equipment itself.
4. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for safety of water that comes into contact with food or is used in the manufacture of ice; conditions and cleanliness of food contact surfaces; prevention of cross-contamination from insanitary object to food and food contact surfaces; proper labeling, storage and use of toxic compounds; control of employee health conditions; and exclusion of pests.
For additional information related to the hazard of pathogen survival through cooking, please refer to Chapter 16 of the Hazard Guide; for additional information related to the hazard of Clostridium botulinum growth and toxin formation please refer to Chapter 13 of the Hazard Guide; for additional information related to introduction of pathogen after pasteurization or cooking please refer to Chapter 18 of the Hazard Guide.
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 and FDA's implementing regulations, including the Seafood HACCP regulations (21 CFR Part 123), the acidified food regulations (21 CFR Part 114), and the Current Good Manufacturing Practice regulations (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: Sherrie L. Krolczyk, Compliance Officer at the letterhead address. If you have questions regarding any issues in this letter, please contact Sherrie L. Krolczyk at 214-253-5312.
Reynaldo R. Rodriguez, Jr.
Dallas District Director