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  5. Yakamoz Sirke Ferm Urunleri Gida Tas San Ve Tic Ltd STI - 631688 - 05/09/2022
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WARNING LETTER

Yakamoz Sirke Ferm Urunleri Gida Tas San Ve Tic Ltd STI MARCS-CMS 631688 —

Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Suat Karaloglu
Recipient Title
Owner
Yakamoz Sirke Ferm Urunleri Gida Tas San Ve Tic Ltd STI

1453 Code No.9 Turgutiu
Turgutlu/Manisa
Turkey

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

United States


May 9, 2022

Re: CMS # 631688

Dear Mr. Karaloglu,

The U.S. Food and Drug Administration (FDA) conducted a Foreign Remote Regulatory Assessment (FRRA) inspection of your juice processing facility located at 1453 Code No. 9 Turgutiu. Turgutlu, Manisa Turkey, on January 1 through February 2, 2022. That inspection revealed violations of the Juice Hazard Analysis and Critical Control Point (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120). At the conclusion of the assessment, the FDA investigator discussed items of concern.

In accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP plan that complies with the requirements of 21 CFR Part 120, renders your juice products adulterated within the meaning of section 402(a)(4) of the Federal Foods, Drug, and Cosmetic Act (the Act) [ 21 U.S.C § 342(a)(4)]. You may find the Act, the Juice HACCP regulation, and the Juice HACCP Hazards and Controls Guidance through the links in FDA’s homepage 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 juice products, can be found on our web site at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Juice/default.htm

We acknowledge your response received via email to the discussion items identified during the FFRA dated 2/14/2022 and 4/13/2022 which included revised HACCP plans for “Concentrated Lemon Juice with Added Ingredients.” However, our review of the documentation revealed that your response is inadequate, as further described in this letter.

We found the following significant deviations:

1. Your HACCP plan does not include control measures that will consistently produce, at a minimum, a 5-log reduction in the most resistant microorganism of public health significance that is likely to occur in the juice, for a period at least as long as the shelf life of the product, as required by 21 CFR 120.24(a). Specifically, the critical limits in your Bolio and Bogopo HACCP plan for lemon and lime juice, revised and signed 02/17/2022, list critical limits of (b)(4) mg/L, hold time (b)(4) hours @ (b)(4)°C ± (b)(4)C. These critical limits are not supported by the validation studies for lemon and lime juice that you provided to the investigator during the remote regulatory assessment. The minimum acidity is below the minimum acidity of the products covered by the studies, and the preservative potassium sorbate was not used in the studies; sodium metabisulfite and sodium benzoate were the preservatives in the studies.

FDA also notes that both Bolio and Bogopo and Leaping Leopard revised HACCP plans do not list the validation and verification procedures (e.g., record review, instrument calibration, process establishment source/validation studies).

The above-identified deviations are not intended to be an all-inclusive list of deficiencies at your food manufacturing facility. It is your responsibility to ensure that your firm is in compliance with all requirements of the Act and federal regulations. You should take prompt action to correct the current deviations. Your failure to promptly correct these deviations may result in administrative and/or regulatory action without further notice.

You should respond in writing within 15 working days from your receipt of this letter. Your response should include documentation reflecting the changes you made, such as a copy of your revised juice HACCP plan for lemon and lime juice products, the validation study demonstrating that you can achieve a five-log reduction, updated label for your lemon and lime juice products, 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. 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 action to refuse admission of your 100% Lemon Juice and 100% Lime Juice products under Section 80 I (a) of the Act (21 U.S.C. § 381 (a)), including subjecting it to 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. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the juice HACCP regulation is Import Alert #20-07. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/importalert 761_.html

You should direct your written reply to Renu Kapoor, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Renu Kapoor via email at Renu.Kapoor@fda.hhs.gov. Please reference CMS # 631688 on any submissions and on the subject line of any emails to us.

Sincerely,
/S/

Amy Barringer
Acting Deputy Director
Office of Compliance
Center for Food Safety and Applied Nutrition

 
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