Inspections, Compliance, Enforcement, and Criminal Investigations
Chloe Foods Corp 04-Sep-08
Department of Health and Human Services
Public Health Service
New York District
September 4, 2008
RETURN RECEIPT REQUESTED
Chief Executive Officer
Chloe Foods Corp.
3301 Atlantic Avenue
Brooklyn, NY 11208-1946
Dear Mr. Themis:
We inspected your seafood processing facility, located at 3301 Atlantic Avenue, Brooklyn, New York 11208-1946 on May 13, 15,16, 20, 23 & 30, 2008. 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 refrigerated, ready-to-eat seafood salads such as "Krab Salad" and "Neptune Salad" 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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plan for refrigerated ready-to-eat seafood products does not list the food safety hazard of pathogen growth and toxin formation at the "receiving processed seafood/fish items" critical control point. It was noted during the inspection that your firm has and implements a standard operating procedure which directs taking [redacted] for various incoming raw materials including all fish products and rejecting any such materials with temperatures above [redacted] however these instructions were not included in your HACCP plan.
2. You must have a HACCP plan that lists the "critical control points" for each identified food safety hazard to comply with 21 CFR 123.6(c)(2). A critical control point is defined in 21 CFR 123.3 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, your firm's HACCP plan for refrigerated ready-to-eat seafood products does not include the in-process storage of histamine species as a critical control point with appropriate critical limits and monitoring procedures. Specifically, our investigator noted that the east kitchen cooler was used to store in-process histamine products such as tuna salad.
3. You must adequately monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110 and to comply with 21 CFR 123.11 (b). However your firm did not adequately monitor the prevention of cross-contamination from insanitary materials to food as well as the condition and cleanliness of food contact surfaces. For example:
(a) On 5/23/08, our investigator observed [redacted] automated fill lines located in the east kitchen with pumps full of old product residues. The residues consisted of moist and dried product on each of the fill line pumps [redacted] fully automated fill lines in the east kitchen and one foot pump operated fill line, upon disassembly, were observed to contain old, yellow, thick product residue on the pump. In addition, the one pneumatic pump that was checked on a fill line in the main kitchen was disassembled and revealed dried potato stuck on the plastic pump face.
(b) On 5/23/08, our investigator noted that a large portion of stainless steel carts are dented and wrinkled on the inside corners. These wrinkles contained trapped food residues, indicating that they were not being cleaned adequately during pre-operational equipment cleaning. Residues of white salad paste, vegetable pieces and potato were observed in the carts throughout the facility.
(c) On 5/20/08, during your firm's manufacturing of ready-to-eat "Krab Salad," our investigator observed an employee in the salad preparation room cleaning floors, walls, and equipment with a spray hose while raw material ingredients were staged adjacent to the employee. Water splatter from the walls, floor, and equipment was observed falling on to carts filled with ready to eat "Krab Salad" surimi chunks, celery, and dressing raw materials. In addition, this same employee was observed on the same day using a large metal mixing utensil to activate the equipment bleed valve and moving a sliding vent cover into place just prior to using this same utensil to move raw material ingredients from a holding cart into the processing machine and manipulating the raw material while inside the equipment.
Our investigator also observed water clean-up operations in the main kitchen. Water spray-over from adjacent packing lines, during cleaning, was observed falling onto adjacent packing lines and uncovered product.
4. You must maintain sanitation control records that, at a minimum, document monitoring and corrections to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for: the safety of water that comes into contact with food or food contact surfaces, maintenance of hand washing and hand sanitizing facilities and proper labeling, storage and use of toxic chemicals required for the processing of your seafood products. Further, although sanitation records are maintained, they do not accurately reflect actual monitoring conducted. For example, the sanitation form for 5/22/08 indicated various pieces of equipment were cleaned, yet they were found to be encrusted with prior production food materials and had not been dismantled in accordance with your firm's written procedures.
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.
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.
It should also be noted that our inspection found the following non-seafood products were processed on the same east kitchen equipment subject to the above HACCP violations:
On 5/16/08, we collected and analyzed a sample of scallion cream cheese which had been processed on the same equipment as your seafood. Based on our analyses, this cream cheese is adulterated within the meaning of section 402(a)(1) of the Act [21 U.S.C. § 342(a)(1)] in that it bears and contains a poisonous or deleterious substance, namely Listeria monocytogenes, (L. monocytogenes) which may render it injurious to health. The FDA Northeast Regional Laboratory in Jamaica, New York notified you of this finding on 6/9/08.
We also note that on 5/5/08, a sample of chopped chicken liver was collected by the United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS). Analysis of this sample also revealed the presence of L. monocytogenes. USDA advised you of this finding on 5/13/08.
We acknowledge receipt of Mr. Perdomo's letter dated 6/16/08 relaying your firm's intended corrective actions relating to the list inspectional observations issued to you on 5/30/08. However, this letter does not adequately address these violations for the following reasons:
1. With respect to item #1 on the form FDA 483, the issue concerned the failure to include sufficient detail regarding the break down and cleaning of all components of the Control [redacted] filling lines in your sanitation monitoring records as well as the completion of this record despite evidence that the equipment had not been adequately cleaned. Sanitation control records are required by 21 CFR 123.11(c) to document, at a minimum, the monitoring and corrections prescribed by 21 CFR 123.11(b). Such monitoring includes the condition and cleanliness of food contact surfaces and prevention of cross-contamination to food.
Your response relays the intent to utilize an updated sanitation monitoring form as a corrective action. Although the revised form included with your response provides a better format for recording pre-operational cleaning and sanitation operations, the form still lacks provisions for breakdown of all the equipment found to contain remnants of prior production, i.e. various points on the [redacted] automated packing lines such as pumps, housings and hoses, by combining this operation under one heading. This revised form also fails to address the safety of water that comes into contact with food or food contact surfaces, maintenance of hand washing and hand sanitizing facilities and proper labeling, storage and use of toxic chemicals required for the processing of your seafood, the monitoring of which is required by 21 CFR 123.11(b). There is also the issue of employees completing the sanitation form although the operations were not adequately performed. As mentioned above, the sanitation form for 5/22/08 indicated various pieces of equipment were cleaned, yet they were found to be encrusted with prior production food materials and had not been dismantled in accordance with your firm's written procedures. In addition, although your sanitation standard operating procedure dated 5/13/08 provides general instructions for the breakdown of equipment; it lacks specific directions in this regard. For example, the directions indicate equipment should be washed with potable water and sanitized with an approved sanitizer, but the temperature of the water and type of sanitizer is not specified. According to 21 CFR 123.11(a), each processor should have and implement a written sanitation standard operating procedures specifying how the processor will meet the sanitation conditions and practices that are to be monitored in accordance with paragraph 21 CFR 123.11 (b).
2. With respect to item #2 on the form FDA483, the issue concerned the failure to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing. Monitoring the condition and cleanliness of food contact surfaces is required by 21 CFR 123.11(b). This observation noted product residues on equipment and filling lines. Your response relays a corrective action of adding another person to conduct pre-op on direct contact equipment and a change in the concentration of the [redacted] Liquid Sanitizer Disinfectant to a lower ppm level [redacted] which reportedly should provide the same effectiveness without a biofilm. During our inspection, a copy of the [redacted] Liquid Sanitizer was obtained. Review of these written instructions revealed the prepared compound delivers individual specific quantities of [redacted] and [redacted] depending upon the amount of water added. The level referenced in your response as a single level of [redacted] does not appear to correspond to the directions for use, nor is there any reference to use at a lower level. Cleaning and sanitizing agents should be used in accordance with manufacturer's instructions and performance of such agents in specific applications should be demonstrated through some validating measures. Processors are required by 21 CFR 123.11(b) to conduct sanitation monitoring with sufficient frequency to ensure, conformance with the conditions and practices specified in part 21 CFR 110.
3. With respect to item #3 concerning residues in the [redacted] carts, again, the issue concerned the failure to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing and monitoring the condition and cleanliness of food contact surfaces as required by 21 CFR 123.11.(b). The response indicates the carts have been added to the preventive maintenance schedule with additional wash rooms to be made available. Although "wagons" are noted on the revised form,, they were also listed on the previous form. There is no specific provision for cleaning the corners and crevices which were observed to harbor prior food residues.
4. With respect to item #4 concerning water splashing onto food materials, the issue is monitoring the prevention of cross-contamination from insanitary objects to food required by 21 CFR 123.11 (b). The response indicates the practice has been modified so that no hosing down will be performed while exposed product is present. While this appears to be an improvement, there is also concern with splashing water from one area to another which may contaminate food processing surfaces even if food is not present at the time. We acknowledge your intent to provide employees with training in this regard, but cleaning standard operating procedures should first be established to avoid cross-contamination in these operations whether or not food is present.
5. Finally, item #5 concerned the lack of a temperature monitoring device in the east kitchen cooler which is used to store in-process food materials such as histamine fish. Your response indicates temperature checks are conducted several times a day, but this method of temperature monitoring is not adequate for such seafood as scombroid species. As recommended in the FDA Fish & Fisheries Products Hazards & Controls Guide, as an alternative, you could monitor storage temperature by monitoring ice or cooling media, or you could utilize a continuous time temperature recording device.
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.
Please send your reply to the Food and Drug Administration, Attention: Lillian C. Aveta. If you have questions regarding any issues in this letter, please contact Lillian Aveta at 718-662-5576.
Otto D. Vitillo
cc: Ray Geer
Chief Operating Officer
Chloe Foods Corp.
3301 Atlantic Avenue
Brooklyn, NY 11208-1946
cc: Mr. Ray Perdomo
Quality Control Manager
Chloe Foods Corp.
3301 Atlantic Avenue
Brooklyn, NY 11208-1946