WARNING LETTER
OOO "TD Baltiyskiy Bereg''
MARCS-CMS 552245 —
April 09, 2018
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Kotlyakova Alena
OOO "TD Baltiyskiy Bereg''
29, B 2, ul. Mineralnaya
Sankt-Peterburg
Sankt-Peterburg
Russia
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
WARNING LETTER
APR 9, 2018
Reference# 552245
Dear Kotlyakova Alena:
On December 26, 2017, a representative of the United States Food and Drug Administration (FDA) obtained a copy of your HACCP plan for your
(b)(4)
ready-to-eat herring in oil products, dated January 11, 2017, from an importer of seafood products, located in the United States, Cascada International Corporation, located in Elizabeth, New Jersey. That importer was found to be importing fish and fishery products from your processing facility.
Review of your HACCP Plan (copy attached), revealed that this plan demonstrates serious deviations from the requirements of the seafood HACCP regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). 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
(b)(4)
ready-to-eat herring in oil products 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 Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at
www.fda.gov.
We found the following significant deviations:
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
(b)(4)
ready-to-eat herring in oil products, dated January 11, 2017, does not identify your finished product storage as a critical control point for controlling the food safety hazard of
Clostridium botulinum
growth and toxin formation identified as
Clostridia
in your plan. According to your product description, your products are
(b)(4)
ready-to-eat raw brined herring fillets (or fillet pieces) in oil packed in
(b)(4)
containers. FDA considers the hazard of
Clostridium botulinum
growth and toxin formation reasonably likely to occur in your
(b)(4)
herring products because they are packed in oil, which creates an anaerobic environment conducive to toxin formation. For these types of
(b)(4)
products that are salted and matured to a point that achieves a water phase salt of at least
(b)(4)
%, or a water activity of below
(b)(4)
, or a pH of
(b)(4)
or below, FDA recommends safe storage and distribute at temperatures of 4.4°c (40°F) or below.
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 your
(b)(4)
ready-to-eat herring in oil products, dated January 11, 2017, does not list a critical limit at CCP No. 1, Maturation Process 12 to control the hazard of
Clostridium botulinum
growth and toxin formation, identified in your plan as
Clostridia
. According to your product description, these products are
(b)(4)
ready-to-eat raw brined herring fillets (or fillet pieces) in oil packaged in
(b)(4)
containers. Although your plan lists critical limits for the "
(b)(4)
:" with specific maturation times, your plan does not identify a targeted end product (i.e., finished product) water phase salt level or finished product water activity level. FDA recommends achieving a finished product water phase salt of at least 5% or higher, or a finished product water activity of below 0.97, or a finished product pH of 5.0 or below. Testing of the finished product should be conducted on each batch or, alternatively, monitoring of the critical factors associated with achieving the final finished product levels should be conducted during the maturation process. Verification testing of finished product should be conducted at least
(b)(4)
every
(b)(4)
months when the HACCP plan lists monitoring of the critical factors for each batch.
3. 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". Specifically, your HACCP plan for your
(b)(4)
ready-to-eat herring in oil products, dated January 11, 2017, lists critical limits:
a. At the "
(b)(4)
" critical control point, your critical limits are not adequate to control the hazard of pathogen growth and toxin formation. Your plan lists critical limits for time from
(b)(4)
hours to up to
(b)(4)
days. FDA recommends you ensure the proper temperature control (i.e., continuously maintaining temperatures at or below 4.4° C) during the maturation and salting processes.
b. At the "
(b)(4)
" critical control point, your critical limits are not adequate to control the hazards of pathogen growth and toxin formation and scombrotoxin (histamine) formation. Your critical limits include temperature exposures that exceed
(b)(4)
°C without any corresponding critical limits for time (i.e., time of exposure at temperatures above
(b)(4)
°C). Specifically, your HACCP plan lists "
(b)(4)
." FDA recommends all unrefrigerated processing, which includes thawing without refrigeration (i.e., above 4.4°C), be limited to a cumulative time of 5 hours when the ambient processing temperatures are above 10°C, but never exceed 21.1°c. When the ambient processing time temperatures exceed 21.1°C or temperatures are not monitored, then the cumulative unrefrigerated processing time should be limited to 2 hours. Alternatively, thawing can be performed under refrigeration at 4.4°C or below with continuous ambient temperature monitoring of the cooler.
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., records for the production of 5 production date codes of the 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 applicable laws and regulations. Submission of the information in English will assist in our review. 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
.
In addition, we have the following comment related to your
(b)(4)
herring in oil process: Because Clostridium botulinum spores are known to be present in the viscera, fish must be eviscerated
before
the
(b)(4)
step, not after, as listed in your "
(b)(4)
".
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. If you have any questions regarding this letter, you may contact Ms. Purnell via email at standra.purnell@fda.hhs.gov. Please reference CMS #552245 on any submissions and within the subject line of any emails to us.
Sincerely,
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
Content current as of:
04/17/2018
Regulated Product(s)
Food & Beverages