Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New England District|
One Montvale Avenue
Stoneham, Massachusetts 02180
FAX: (781) 587-7556
CMS # 268756
UNITED PARCEL SERVICE
January 23, 2012
Mr. Bayard Douty
Douty Brothers, Inc.
10 Portland Fish Pier
Portland, ME 04105
Dear Mr. Douty:
We inspected your seafood processing facility, located at 10 Portland Fish Pier on December 13 through 30, 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 ready-to-eat (RTE), seafood products, including refrigerated ready to eat (RTE) lobstermeat and RTE fluke 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 through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However your firm did not have a HACCP plan for RTE fluke to control the food safety hazard of parasites, pathogen growth and toxin formation.
We acknowledge receipt of your response to the FDA-483 on January 5, 2012. We note that you will no longer be handling fresh fluke. Keep in mind that if you plan to handle fresh fluke in the future, you will need to develop a HACCP plan for this product.
2. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan for cooked "Lobster Meat" to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedures that were described under your critical control points (CCP's) for cooking and storage. For example:
a. Your cooking critical limit states that the internal product temperature should be (b)(4)F at the end of the cook cycle. We observed that you are not taking the internal temperature of the lobster meat during cooking.
b. Your storage critical limit states that you will check the adequacy of ice for cooked lobster meat twice a day. We observed that you are not performing this step for cooked lobster meat stored at your facility.
3. You must implement the record keeping system that is listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm does not record monitoring observations at the cooking or storage critical control points to control a pathogen hazard listed in your HACCP plans for cooked "Lobster Meat" or Tuna.
4. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with CGMP requirements in 21 CFR 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the condition and cleanliness of food contact surfaces, maintenance of hand washing facilities, and 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 the following observations made by our FDA Investigator during our inspection:
• employees scooping ice from the floor beneath the ice chute and using that ice to chill RTE lobster and fish.
• an employee picking cooked lobster tails and claws off the floor and placing them back on the cooking table.
• an employee in charge of lobster cooking using the same blue gloves to handle live lobsters as well as cooked lobster claws and tails.
• an employee washing a stainless steel lobster cooking container directly on the floor inside the lobster cooking room and then storing it on the floor.
• an employee using orange plastic baskets previously used to hold live lobsters to hold cooked lobster without being washed, rinsed and sanitized between raw and RTE use.
• ceilings directly over lobster tanks to have exposed insulation.
• openings under the shipping and receiving bay door and also under the bay door leading to the live lobster tank.
• On December 13, 2011, the hand washing sink located in the lobster cooking room did not have hot water.
We acknowledge receipt of your undated response on January 5, 2012. Your response is unacceptable because it does not provide any documentation that these deficiencies have been corrected and there is no assurance that your proposed correction will prevent re-occurrence.
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: Karen N. Archdeacon, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Ms. Archdeacon at 781-587-7491.
Mutahar S. Shamsi
New England District Office