Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
August 3, 2015
VIA EXPRESS DELIVERY
Nadeem Y. Merchant, Owner
Plot No. 305, GIDC Estate
Veraval, Gujarat, India 362269
Reference # 472941
Dear Mr. Merchant:
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, Keshodwala Foods, located at Plot No. 305 GIDC Estate, Veraval, India on May 22-23, 2015. During that inspection, we found that you had violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA 483, Inspectional Observations, listing the observations made at your firm.
We acknowledge receipt of your responses sent via email on May 26, 28, and July 6, 2015. Your responses from May included descriptions of your corrective measures and photographs. Your response from July included a revised HACCP plan for your scombroid fish dated May 25, 2015. We have evaluated the documentation and found that you have continuing serious deviations of the seafood HACCP regulation, as further explained in this letter.
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 scombroid fish products, Indian mackerel, Spanish mackerel, and mahi mahi are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
You may find the Act, the seafood HACCP regulation, and the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on FDA's home page at www.fda.gov. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products, can be found on our web site at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatorylnformation/Seafood/ucm2018426.htm.
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 revised HACCP plan dated May 25, 2015, entitled "Scombroid Fishes" does not list a critical control point or multiple critical control points for processing to control histamine formation as a result of cumulative exposure to unrefrigerated conditions. Your firm conducts processing operations such as (b)(4). FDA recommends that you include controls in your HACCP plan to limit the cumulative amount of time that the fish are exposed to ambient temperatures above 40°F (4.4°C) during unrefrigerated processing. FDA further recommends that you include any extended storage periods when the fish are held in ice, as additional critical control points.
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 123.6(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 revised HACCP plan dated May 25, 2015, for "Scombroid Fishes" lists critical limits, "(b)(4)", at the R. M. Receiving critical control point that are not adequate, by themselves, to control histamine formation. Specifically, your plan does not list a critical limit for decomposition. FDA recommends that a sensory examination of a representative sample of scombrotoxin-forming fish show decomposition (persistent and readily perceptible) in less than 2.5% of the fish in the sample. For example, no more than 2 fish in a sample of 118 fish may show signs of decomposition.
Furthermore, although your plan lists a critical limit for internal temperature, which is adequate to control histamine formation that is reasonably likely to occur onboard the harvest vessel (at the time of off-loading from the harvest vessel), a critical limit for temperature is not adequate, by itself, to control histamine formation that is reasonably likely to occur during transport from the harvest vessel to the processing plant. For transit control, FDA recommends that:
a. For fish delivered refrigerated (not frozen): All lots received are accompanied by transportation records that show that the fish were held at or below an ambient or internal temperature of 40°F (4.4°C) throughout transit; OR
b. For fish delivered under ice: Fish are completely surrounded by ice at the time of delivery; OR
c. For fish delivered under ice on an open-bed truck;
i. Fish are stored completely surrounded by ice; AND
ii. The internal temperature of the fish at the time of delivery is 40°F 4.4°C) or below; OR
d. For fish delivered under chemical cooling media such as gel packs;
i. There is an adequate quantity of cooling media that remain frozen to have maintained product at an internal temperature of 40°F (4.4°C) or below throughout transit; AND
ii. The internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below; OR
e. For fish delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less (optional control strategy);
i. Time of transit does not exceed 4 hours; AND
ii. Internal temperature of the fish at the time of delivery does not exceed 40°F (4.4°C).
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, your firm's revised HACCP plan dated May 25, 2015, entitled "Scombroid Fishes" lists monitoring procedures at the R.M. Receiving critical control point that are not adequate to control histamine formation. Specifically,
a. Your plan indicates that you will measure the internal "(b)(4)." To control histamine formation that is reasonably likely to occur onboard the harvest vessel, FDA recommends measuring the internal temperature of a representative number of the largest fish in each lot at the time of off-loading from the harvest vessel, concentrating on any fish that show signs of having been mishandled, and that you measure a minimum of 12 fish unless there are fewer than 12 fish in the lot, in which case you should measure all the fish in the lot. To control histamine formation that is reasonably likely to occur during transport from the harvest vessel to the processing plant when using internal temperature as a parameter, FDA recommends measuring the internal temperature of a representative number of fish from throughout the shipment at delivery, in conjunction with measuring another parameter, as indicated in the previous citation (see #2 above).
b. Your plan indicates that you will measure "(b)(4)" in "(b)(4)." FDA recommends measuring the amount of decomposition in the lot by examining at least 118 fish, collected representatively throughout each lot (or the entire lot, for lots smaller than 118 fish).
c. Your plan indicates that you will measure histamine by "(b)(4)." FDA recommends measuring the histamine content in the fish flesh by testing a minimum of 18 fish, collected representatively throughout each lot (or the entire lot when there are fewer than 18 fish in the lot), for every lot received. 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 if the critical limit is reduced accordingly. For example, a sample of 18 fish may be com posited into 6 units of 3 fish each, provided the critical limit is reduced from 50 ppm to 17 ppm for each unit.
4. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan included in your revised HACCP plan entitled "Scombroid Fishes" at the R.M. Receiving critical control point is not adequate to control histamine formation. Specifically, your plan indicates that "(b)(4)." FDA recommends that:
a. For a deviation from the critical limit for internal temperature, in addition to rejecting the lot, you also discontinue use of the supplier, until evidence is obtained that the identified harvesting and onboard practices have been improved; or discontinue use of the supplier or carrier, until evidence is obtained that the identified transportation-handling practices have been improved, as appropriate.
b. For a deviation from a critical limit for decomposition:
i. Chill and hold the product until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the lot, including all fish in the lot that show evidence of decomposition (persistent and readily perceptible odors) (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; AND
ii. If any fish in the lot are to proceed into commerce for food use, perform a sensory examination of all fish in the lot to ensure that no decomposed fish proceed; AND
iii. Any individual fish found to be decomposed (persistent and readily perceptible) should be destroyed or diverted to a non-food use; OR
iv. Reject the lot.
c. For a deviation from the critical limit for histamine, in addition to rejecting the lot, you also discontinue use of the supplier until evidence is obtained that the identified harvesting and onboard practices have been improved.
You should respond in writing within 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_ia/ialist.html.
Additionally, Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. Are inspection is conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of there-inspection and assessing and collecting there-inspection fees (21 U.S.C. § 379j- 31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
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, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Purnell via email at firstname.lastname@example.org.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition