- Keshodwala Foods Unit - II
- Issuing Office:
- Center for Food Safety and Applied Nutrition
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||College Park, MD 20740 |
JUL 7, 2016
VIA EXPRESS DELIVERY
Nadeem Y. Merchant, Partner
Keshodwala Foods- Unit II
Plot No. 305, GIDC Estate
Dear Mr. Merchant:
In response to a request from the U.S. Food and Drug Administration for HACCP related documentation associated with the processing of your fish and fishery products your firm provided a process flow chart for scombrotoxin (histamine) forming fish, a process description, a hazard analysis, and a HACCP plan for scombroid (histamine-forming) fish sent via email on April 5, 2016. Our evaluation of that HACCP plan and supporting documentation revealed serious deviations from the requirements of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21 Code of Federal Regulations, Part 123 (21 CFR 123), as further explained in this letter.
In accordance with 21 CFR 123.6(g), failure of a processor offish or fishery products to have and implement a HACCP plan that complies with th.is 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 scombroid fish are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
Your significant deviations are 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, your firm's HACCP plan for "Scombroid Fishes (Histamine Forming Fishes)" does not list the critical control points of raw material storage, in-process iced storage and unrefrigerated processing for controlling the food safety hazard of scombrotoxin (histamine) formation. Once your firm has included these critical control points in your HACCP plan, FDA recommends that the following critical limits be established:
a. For raw material and in-process storage when fish are stored under ice, we recommend that the product is completely and continuously surrounded by ice throughout the storage period.
b. For processing (e.g., cleaning, packing, and labeling) of scombrotoxin forming fish that have not been previously frozen or heat processed sufficiently to destroy scombrotoxin-forming bacteria:
• The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 4 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C);
• The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 8 hours, cumulatively, as long as no portion of that time is at temperatures above 70°F (21.1°C).
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." However, your firm's HACCP plan for "Scombroid Fishes (histamine-forming fishes)" lists critical limits at the 'Receiving' critical control point that are not adequate to control the food safety hazard of scombrotoxin (histamine) formation. As a primary processor receiving the fish directly from the harvest vessels, FDA recommends that your firm's HACCP plan list critical limits for harvest vessel records, or histamine testing, and the internal temperature of a representative number of the largest fish in a lot, at the time of off-loading from the harvest vessel to ensure that appropriate harvesting and onboard practices are used onboard the harvest vessel. For more information on controlling the scombrotoxin hazard, FDA recommends you review Chapter 7 of the Fish and Fishery Products Hazards and Control Guidance - Fourth Edition. This Guidance can be found at the following web address: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatorylnformation/Seafood/ucm2018426.htm
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, the firm's HACCP plan for “Scombroid Fishes (Histamine Forming Fishes )” lists monitoring procedures for internal temperature of the fish and sensory examination at the 'Receiving' critical control point that are not adequate to control scombrotoxin formation. FDA recommends monitoring:
a. The internal temperature of the fish by using a temperature-indicating device (e.g., a thermometer) to determine internal product temperatures in a representative number of fish randomly selected from throughout the shipment, at delivery. Measure a minimum of 12 fish, unless there are fewer than 12 fish in a lot, in which case measure all of the fish. Lots that show a high level of temperature variability or lots of very small fish may require a larger sample size;
b. The amount of decomposition in the lot by conducting sensory examination of at least 118 fish, collected representatively throughout each lot (or the entire lot, for lots smaller than 118 fish). Additional fish should be examined if variability in fish-to-fish histamine content is expected to be high. Lots should consist of only one species of fish; for vessels delivering multiple species, testing should generally be done separately on each species. All fish within a lot should have a similar history of harvest.
4. Because you chose to include a corrective action plan in your HACCP plan, your described corrective action must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for Scombroid Fishes (Histamine Forming Fishes) at the 'Receiving' critical control point to control the food safety hazard of scombrotoxin formation are not appropriate.
a. When the critical limit for internal temperature of the fish at the time of delivery has not been met, FDA recommends that firms:
• Chill and hold the affected lot (i.e., fish of common origin) until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the lot, including any fish measured to have temperatures that exceeded the critical limit (or the entire lot for lots smaller than 60 fish). Reject the lot if any fish are found with histamine greater than or equal to 50 ppm. The fish collected for analysis may be composited for analysis if the action point is reduced accordingly. For example, a sample of 60 fish may be composited into 20 units of 3 fish each provided the action point is reduced from 50 ppm to 17 ppm for each unit;
• Reject the lot;
• Discontinue use of the supplier or carrier until evidence is obtained that the identified transportation-handling practices have been improved.
b. When the sensory examination critical limit has not been met, FDA recommends that in addition to rejecting the lot, firms discontinue use of the supplier until evidence is obtained that the identified harvesting and onboard practices and controls have been improved.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)) including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert # 16-120. You may view this alert at: http://www.accessdata.fda.gov/cms_ ialialist.html
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation, and the Good Manufacturing Practice regulation (21 CFR 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 Food and Drug Administration, Attention: Standra Purnell, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement Office of Compliance, 5001 Campus Drive, College Park, MD 20740 U.S.A. Please reference #4971 01 on any submissions and within the subject line of any emails to us. If you have any questions regarding this letter, you may contact Ms. Purnell via email at email@example.com
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition