Inspections, Compliance, Enforcement, and Criminal Investigations
Blount Seafood Corporation 1/13/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District
UNITED PARCEL SERVICE
January 13, 2012
Mr. F. Nelson Blount
Blount Seafood Corporation
630 Currant Road
Fall River, MA 02720
Dear Mr. Blount
We inspected your seafood processing facility, located at 630 Currant Road, Fall River, MA on November 17-18, 2011, November 21, 2011, November 28, 2011 and December 6, 2011. 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 & 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 retail and bulk, refrigerated modified atmosphere seafood soups are adulterated, in that they 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 through links in FDA's home page at www.fda.gov.
We have reviewed your firm’s response of December 27, 2011 and note that it lacks sufficient corrective actions.
Your significant violations were as follows:
1. 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 the critical control points, to comply with 21 CFR 123.6 (a) and (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." However, our review found the following:
A. Your firm’s HACCP plan for Bulk Soups and Retail Soups does not list the critical control point of (b)(4) during the manufacturing process or (b)(4) for controlling the food safety hazard(s) of clostridium botulinum (C. Bot) and other pathogens.
We acknowledge receipt of your written response dated December 27, 2011. We understand that you are continuing to evaluate this process and will not have a permanent corrective action plan until January 27, 2012.
B. Your firm’s HACCP plan for frozen Bulk Soups and frozen Retail Soups does not list the critical control point for receipt of and/or the generation of finished product labeling for controlling the food safety hazard(s) of clostridium botulinum (C. Bot). All modified atmosphere packaged frozen bulk and retail soup finished product labels must contain a “keep frozen” statement (e.g., “important, keep frozen until used, thaw under refrigeration immediately before use.)”.
In your written response dated December 27, 2011, you indicated your labels and HACCP Plans will be updated and will have a permanent action plan by January 27, 2012. In your response to this letter, please provide us with your updated HACCP Plan and finished product labels demonstrating that these changes have been implemented.
2. You must have a HACCP plan that 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 plan for your fresh seafood bulk and retail soups lists a critical limit, of (b)(4) at your (b)(4) control points that is not adequate to control C. Bot and other pathogens.
We acknowledge receipt of your written response dated December 27, 2011. We understand that you have updated your HACCP Plan for Bulk Soups; however you did not provide documentation demonstrating that you are meeting your revised critical limit and you are continuing to evaluate this process and will not have a permanent corrective action plan until January 27, 2012.
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and frequency for each critical control point, to comply with 21 CFR 123.6 (c) (4). However, your firm’s HACCP plan for bulk and retail soups lists a monitoring procedure of “visual check for allergens in recipe on finished product label” and frequency of “New and Changed product label approval” at the finished product labeling critical control point that is not adequate to control allergens. As evidenced by your firm’s voluntary recall initiated on 1/11/2012 for your Natural Rip Roarin’ Crab Soup Product as a result of applying incorrect back panel labels, containing incorrect ingredient, nutrition and allergen statements.
This violation and the resulting recall are of particular concern because this is the fourth undeclared allergen related recall by Blount Seafood Corporation since 2008. The following is a summary of the four recalls:
• 01/2012 - - Crab Soup; Reason: Undeclared milk, crab and wheat
• 11/2011 – Turkey Gravy ; Reason: Undeclared Hydrolyzed Soy Protein
• 05/2011 – Turkey Gravy; Reason: Undeclared hydrolyzed Soy Protein
• 05/2008 – New England Clam Chowder Soup; Reason: Undeclared Shrimp
All of these recalls resulted from products containing undeclared commonly known allergens, such as soy, milk, wheat, shrimp and crab. Undeclared ingredients that are known allergens are of particular concern to the agency. FDA has received an increasing number of reports concerning consumers who have experienced adverse reactions following exposure to an allergenic substance in foods. For sensitive individuals, the presence of allergens in food is potentially life threatening. Ingredients that are among the most commonly known to cause serious allergic responses are milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and derivatives of these products.
In your written response dated December 27, 2011, you indicated your HACCP Plan was updated to include the monitoring procedure of “labels are checked during application process to ensure correct label is applied”. This most recent recall demonstrates the seriousness of improperly reviewing product labels for allergens. You should take prompt action to correct the conditions that led to the above described violation and the other undeclared allergen related recalls listed above. In your response to this letter please provide us with documentation demonstrating your revised HACCP Plan monitoring procedures have been fully implemented.
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. A regulatory meeting with you will be scheduled after receipt and review of your response.
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: Lori A. Holmquist, Compliance Officer, 330 Civic Center Drive, Suite 1, Box 4, Augusta, ME 04330. If you have questions regarding any issues in this letter, please contact Lori A. Holmquist at 207.622.8268 x
Mutahar S. Shamsi
New England District Office