WARNING LETTER
Tamara Fruit CJSC
MARCS-CMS 685855 —
June 21, 2024
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Juice
Recipient:
Recipient Name
Boris Hovhannisyan
Recipient Title
Owner
Tamara Fruit CJSC
9 St. 1 Lane 2 Deadblock
0214
Karbi
Aragatsotn
Armenia
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
WARNING LETTER
Reference #: CMS 685855
Dear Mr. Hovhannisyan,
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility, located at 9 St. 1 Lane 2 Deadblock, Karbi, Aragatsotn Armenia 0214 from February 12 to 14, 2024. Your firm manufactures products including juice-based nectars and acidified foods. The inspection revealed serious deviations of the juice Hazard Analysis and Critical Control Point (HACCP) Systems regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120), the Emergency Permit Control regulation (21 CFR 108), and the Acidified Foods regulation (21 CFR 114). At the conclusion of the inspection, an FDA-483, Inspectional Observations, was issued listing the serious deviations found at your firm. To-date, we have not received a response from you regarding the FDA-483.
Accordingly, we have determined that your juice-based nectars and acidified Imam-Bayaldi products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
As a manufacturer of acidified food products intended for export to the United States, you are required to comply with the Act, and the Federal regulations relating to the processing of acidified foods. As outlined in the regulations, a commercial processor of acidified foods that does not adhere to all the mandatory requirements of 21 CFR 108.25 and 21 CFR 114 could be subjected to an immediate application of the emergency permit control provisions of section 404 of the Act (21 U.S.C. § 344). As stated in 21 CFR 108.25(j), for imported products, in lieu of issuing an order of determination that a permit is required before products from such commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor's products under section 801 of the Act (21 U.S.C. § 381), when offered for entry into the United States.
Further, in accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP system that complies with 21 CFR 120.6, 120.7, and 120.8, or otherwise to operate in accordance with the requirements of 21 CFR 120, renders the juice products adulterated within the meaning of section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)).
You can find the Act, the Emergency Permit Control regulation, the Acidified Food regulation, and the Juice HACCP regulation through links on FDA’s home page at www.fda.gov.
Your significant violations are as follows:
Juice HACCP Violations (21 CFR 120):
1. Your HACCP plan must, at a minimum, list all food hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(b)(1). A food hazard is defined in 21 CFR 120.3(g) as “any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.” However, your HACCP plan for your apple, apricot, and peach juice-based nectar beverages packaged in glass jars, does not list the food hazards of metal from the
(b)(4)
steps, and glass due to packaging. Further, your HACCP plan for your apple juice-based nectar product does not list the food hazard of patulin.
2. You must maintain sanitation standard operating procedure records that, at a minimum, document monitoring and corrections, to comply with 21 CFR 120.6(c). However, your firm did not maintain sanitation operating procedure records for:
Safety of the water that comes into contact with food or food contact surfaces or that is used in the manufacture of ice;
Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants;
Proper labeling, storage, and use of toxic compounds; and
Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces.
Acidified Foods Violations (21 CFR 114):
1. You did not maintain processing and production records showing adherence to the scheduled process, as required by 21 CFR 114.100(b). Specifically, our investigator reviewed your scheduled process filed with the FDA for your Imam-Bayaldi product, as packaged into container sizes of
(b)(4)
. Your scheduled process identifies a minimum initial temperature (IT) of
(b)(4)
º F. However, you do not maintain records to document your adherence to the minimum initial temperature.
2. Each container is not marked with an identifying code specifying the establishment where the product was packed, product contained therein and packing period, as required by 21 CFR 114.80(b). Specifically, your product containers are only marked with production and best-by dates.
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. More specifically, your response should include documentation and information that would assist us in evaluating your corrections, including processing records for five lots of product produced over at least five days. 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 believe that the foods you import are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
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 acidified food 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, examples of Import Alerts that conveys information specific to foreign firms that are not in compliance with juice HACCP and acidified food regulations (21 CFR 108, 114, and 120), are Import Alert #99-38, “Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods Due to Inadequate Process Controls” and Import Alert #20-07, “Detention Without Physical Examination of Juice from Foreign Processors Not in Compliance with Juice HACCP Regulation”. These alerts can be found on FDA's web site at https://cms.fda.gov/vts/imports_publish/private/importalert_761.html and https://www.accessdata.fda.gov/CMS IA/importalert_1132.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 Emergency Permit Control regulation (21 CFR 108), the Acidified Foods regulation (21 CFR 114), the Juice HACCP regulation (21 CFR 120), and the current Good Manufacturing Practice regulation (21 CFR 117).
Please send your reply to the Food and Drug Administration, Attention: Amy R. Glynn, Compliance Officer, Food Adulteration Assessment Branch, Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A., or send via email at amy.glynn@fda.hhs.gov. Please reference CMS # 685855 on any submissions and within the subject line of any emails to us.
Sincerely,
/S/
Ann M. Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
Content current as of:
06/25/2024
Regulated Product(s)
Food & Beverages
Juice