Inspections, Compliance, Enforcement, and Criminal Investigations
New Orleans Fish House 03-Mar-06
Department of Health and Human Services
Public Health Service
New Orleans District
March 3, 2006
WARNING LETTER NO. 2006-NOL-05
Mr. William B. Borges, Jr., President
New Orleans Fish House
921 South Dupre Street .
New Orleans, LA 70125
Dear Mr. .Borges:
On January 10, 11 and 13, 2006, a U. S. Food and Drug Administration (FDA) investigator inspected your seafood processing facility, located at 79,5 East McDowell Road, Jackson, Mississippi. This investigator documented serious deviations from the Seafood Hazard Analysis Critical *Control Point (HACCP) regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan which complies with this section or otherwise operate in accordance with the requirements of this part, renders the fish or fishery products adulterated within the meaning of Section 402(ax4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 USC 342(a)(4). Accordingly, your fresh, refrigerated seafood products are adulterated, as 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 regulations, and the Fish and Fisheries Products Hazards Controls Guidance: Third Edition (the . Guide) through links in FDA's Internet home page at www.fda.gov.
The deviations observed are as follows:
1. You must implement the record keeping system you list in your HACCP plan to comply with 21 CFR 123.6(b). However, your firm does not record monitoring observations at the receiving and distribution critical control points to control scombrotoxin (histamine) formation listed in your HACCP plan for fresh fish products, and you did not record monitoring observations at the storage and packaging critical control points for these same products, to control histamine formation, from December 22, 2005 to January 10, 2006. You also did not record monitoring observations at the storage and distribution critical control points to control pathogen growth as listed in your HACCP plan for crabmeat and scallops for the time period of December 22, 2005 to January 10, 2006.
2. You must conduct a hazard analysis to determine whether there are food safety hazards reasonably likely to occur and have a HACCP plan listing, at minimum , 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 carr as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's HACCP plan for crabmeat and scallops does not list the critical control point of receiving for controlling the food safety hazard of pathogen growth.
3. You must conduct a hazard analysis to determine whether there are food safety hazards reasonably likely to occur, and you must have a written HACCP plan to control any food safety hazards reasonably likely to occur to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for raw, refrigerated fish for consumption without cooking,by the end user to control the food safety hazard of parasites.
4. You must have a HACCP plan listing, at minimum, monitoring procedures for each critical control point to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for large tuna, mahi mahi, bluefish, escolar, mackerel, amberjack, yellowtail, and wahoo, and your HACCP plan for crabmeat and scallops, list monitoring procedures at the critical control point of packaging and storage . for fish and other seafood products not adequate to control pathogen growth and/or histamine formation. Your HACCP plans list a critical limit of monitoring for the presence of ice on these products, but your employees monitor room temperature in the processing and cooler/storage room. This practice is not mentioned in your HACCP plan.
5. You must maintain sanitation control records documenting, at minimum, monitoring and corrections to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for safety of water contacting food or food contact surfaces, including water used to manufacture ice; condition and cleanliness of food contact surfaces; prevention of cross-contamination from insanitary objects; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration; proper labeling, storage, and use of toxic chemicals; control of employee health conditions; and, exclusion of pests required for the processing of raw, refrigerated fish (for human consumption), crabmeat (refrigerated, cooked), and scallops from December 22, 2005 to January 10, 2006.
Histamine is a chemical which may cause serious illness at levels as low as 200 parts per million (ppm) and is commonly the result of spoilage of fish due to temperature abuse. Fish processors should take all precautions necessary to reduce the risk of development of histamines. This can be achieved by creating and following a HACCP plan and maintaining temperature monitoring records to show the temperature of fish being controlled. We strongly recommend you take corrective action as soon as possible.
The observed deviations were brought to the attention [redacted] District Manager, during the discussion of the Form FDA 483 issued to [redacted] on January 13, 2006. We may take further action if you do not promptly correct these violations. For instance, we may seize your products and/or enjoin your firm from operating.
We are aware [redacted] made a verbal commitment to correct the observed deficiencies during the inspection. However, you must respond in writing, within 15 working days of the receipt of this letter, of the steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. Your response should outline the specific things you are doing to correct these deviations. You should include in your response documentation such as copies of receiving records, temperature monitoring records, thermometer calibration records, or other useful information to assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect you to explain the reason for your delay and state when you will correct any remaining deviations.
This letter may not list all the deviations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act, the Seafood HACCP regulations, and Current Good Manufacturing Practice regulations (21 CFR 110). You have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations .
Please send your reply to the U.S. Food and Drug Administration, Attention: Cynthia R. Crocker, Compliance Officer, 100 W. Capitol Street, Suite 340, Jackson; Mississippi 39269. If you have questions regarding any issue in this letter, please contact Ms. Crocker at (601) 965- 4581, extension 106.
Patricia K. Schafer
Acting District Director
New Orleans District