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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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OLMA-XXI Inc 18-Jan-08

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

New York District

158-15 Liberty Avenue
Jamaica, NY 11433


WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

January 16, 2008

Igor Eliachove
President.
OLMA-XXI Inc.
127 42nd Street
Brooklyn, New York 11232

REF: NYK-2008-07

Dear Mr. Eliachove:

We inspected your seafood processing facility, located at 127 42nd Street, Brooklyn, New York 11232 on September 19 and 21, 2007 and October 22 and 23, 2007. 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, vacuum packed smoked fishery products, including smoked salmon, smoked paltus, and smoked mackerel; your refrigerated, ready-to-eat, vacuum packed shmaltz/brined herring; and your refrigerated, unpasteurized, ready-to-eat reduced oxygen packed salmon caviar/salmon roe 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:

• 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 does not have a HACCP plan for refrigerated, ready-to-eat, vacuum packed smoked fishery products, including smoked salmon, smoked paltus, and smoked mackerel, and refrigerated, ready-to-eat, vacuum packed shmaltz/brined herring to control the food safety hazards of pathogen growth and toxin formation, including Clostridium botulinum toxin formation, and additionally, for the scombroid species fish, herring and mackerel, to control the food safety hazard of scombrotoxin formation.

• You must have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(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 refrigerated unpasteurized ready-to-eat reduced oxygen packed salmon caviar/salmon roe does not list the critical control points of:

1. Receiving, to control the water phase salt levels in the raw material. Your firm discussed that your current method of operation includes monitoring the labels of the incoming roe to ensure that the [(b)(4)] are declared at or [(b)(4)] However, you do not list monitoring of incoming raw material as a critical control point in your plan. Moreover, please be advised that we do not recommend bulk label review as a monitoring strategy because label review does not ensure that the [(b)(4)] critical limits are consistently met for each batch.
2. Draining, to control the [(b)(4)] and to control pathogen growth. Extended drain times may affect the final [(b)(4)] and may lead to time and/or temperature abuse, thus creating the potential for pathogen growth.
3. Refrigerated storage, to control the food safety hazard of pathogen growth and potential toxin formation, including Clostridium botulinum growth and toxin formation in your finished product storage. We note that your firm uses [(b)(4)] walk-in refrigerators for thawing your frozen raw materials and for storing your finished products. Pathogen growth and potential toxin formation, including toxin formation from Clostridium botulinum, are reasonably likely hazards associated with these operations. Consequently, you must include in your HACCP plan a critical control point for monitoring refrigerated storage conditions. FDA suggests the use of a continuous monitoring device such as a continuous temperature data logger for monitoring refrigerated storage temperatures on each of your refrigerators. We also recommend a daily check of the recorded temperatures to ensure that your critical temperature limits have not been exceeded. We also recommend a daily check of the monitoring equipment itself to ensure that it is operating properly. For more information on the hazard of Clostridium botulinum growth and toxin formation, please refer to Chapter 13 of the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition.

• You must verify that your HACCP plan is adequate to control the food safety hazards that are reasonably likely to occur and that the plan is being effectively implemented, to comply with 21 CFR Part 123.8. Specifically, in order to verify that your plan adequately controls the food safety hazard of pathogen growth and potential toxin formation, including Clostridium botulinum growth and toxin formation in your finished product, your firm must conduct, or have conducted for you, a scientific study to ensure that your process, in combination with the verified [(b)(4)] of the raw material coupled with your [(b)(4)] will consistently result in an adequate [(b)(4)] in the finished product. The purpose of the study is to establish the necessary critical limits and conditions that must be monitored at each critical control point during processing, in order to verify that the final expected [(b)(4)] is achieved for the finished product. We also recommend that you periodically test your finished products, as part of your overall verification procedures, to demonstrate that your process is effective and continues to result in the [(b)(4)] referenced in your CCP form, necessary to control Clostridium botulinum in the finished product.

• You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for the processing of your refrigerated unpasteurized ready-to-eat reduced oxygen packed salmon caviar/salmon roe, documenting: safety of water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice; condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments; prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product; 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 compounds; control of employee health conditions; and exclusion of pests.

In addition, the Food and Drug Administration has determined that your facility is subject to the registration requirement in Section 415 of the Act (21 U.S.C. § 350d) and our implementing regulation at 21 CFR Part 1, Subpart H. The failure to register a facility as required is a prohibited act under Section 301 (dd) of the Act (21 U.S.C. § 331(dd)). Our records indicate that, to date, your facility has not been registered with FDA.

The owner, operator, or agent in charge of your facility, or an individual authorized by your facility's owner, operator, or agent in charge, should register the facility with FDA immediately. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.

Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:

U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857

When completed, the form may be faxed to 301-210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.

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: Anna Alexander. If you have questions regarding any issues in this letter, please contact Anna Alexander at 718-662-5683.

Sincerely,

/S/

Otto D. Vitillo
District Director