WARNING LETTER

Swity d.o.o. MARCS-CMS 682450 — May 16, 2024

Delivery Method:: Via Express Delivery
Product:: Food & Beverages

Recipient:: Recipient Name

Enis Bajramovic; Recipient Title

Director; Swity d.o.o.; Sarajevska Ulica 122
Gradacac
76250 Federacija Bosne i Hercegovine
Bosnia & Herzegovina

Issuing Office:: Center for Food Safety and Applied Nutrition; United States

WARNING LETTER

Reference #: CMS 682450

Dear Mr. Bajramovic,

The U.S. Food and Drug Administration (FDA) conducted an inspection of your acidified foods processing facility, located at Sarajevska Ulica. Gradacac, Federacija Bosne i Hercegovine, Bosnia-Hercegovina 76250, on January 22 and 23, 2024. The inspection revealed serious violations of the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108) and the Acidified Foods regulation (21 CFR Part 114). At the conclusion of the inspection, an FDA-483, Inspectional Observations, was issued listing the serious deviations found at your firm. We received your written responses on February 13, 2024, and April 16, 2024, which included corrective actions and supporting documentation taken by your firm in response to the observation noted on the FDA-483. Our evaluation of the documentation provided in your responses revealed that your response was not adequate, as further described in this letter.

As a manufacturer of acidified food products intended for export to the United States, you are required to comply with the Federal Food Drug and Cosmetic Act (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. Violations of the mandatory requirements set forth in 21 CFR 108.25 and 21 CFR 114 renders your acidified yellow pepper fillet products adulterated within the meaning of section 402(a)(4) of the Act (21 U.S.C. 342(a)(4)) in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act and the acidified food regulations through links in FDA's home page at www.fda.gov.

Your significant violations are as follows:

1. Your firm failed to process a food in conformity with at least the scheduled process filed with FDA, as required by 21 CFR 108.25(c)(3)(i). Specifically, our investigator reviewed your scheduled process filed with the FDA for your yellow pepper fillets product, packaged into container sizes of (b)(4) * (b)(4) ((b)(4) oz). Your scheduled process identifies a finished equilibrium pH of (b)(4), a minimum initial temperature ((b)(4)) of (b)(4)º F, a processing time of (b)(4) minutes, a processing temperature of (b)(4)º F, and a maximum fill weight of (b)(4) oz.

Between September 1 and 2, 2022, you manufactured (b)(4) batches of yellow pepper fillets in container sizes of (b)(4) liters ((b)(4) oz). However, you are not processing your yellow pepper fillets in accordance with your scheduled process, as described below.

a. You did not monitor the critical parameters of finished product pH and maximum fill weight for your yellow pepper fillets processed on September 1 and 2, 2022. During the inspection, our investigator requested to see the finished product equilibrium pH records and maximum fill weight records for your yellow pepper fillets processed on September 1, 2022. You stated that you do not measure the pH of the finished product at your firm, or at any external laboratory. You also stated that you do not measure the fill weight of the finished product. Moreover, your container size of (b)(4) liters ((b)(4) oz), as identified on your processing records for yellow pepper fillet products produced between September 1 and 2, 2022, can accommodate approximately (b)(4) oz. more product than that of the maximum allowable fill weight identified in your scheduled process.

b. You processed (b)(4) batches of yellow pepper fillet products between September 1 and 2, 2022 for (b)(4) minutes, which is (b)(4) minutes below the processing time identified in your scheduled process.

c. You processed four batches of yellow pepper fillet products between September 1 and 2, 2022 at temperatures less than or equal to (b)(4)°C ((b)(4)°F). However, your processing temperature identified in your filed scheduled process is (b)(4)º F. Furthermore, your HACCP plan and processing record for products produced between September 1 and 2, 2022, identify a pasteurization temperature parameter of (b)(4) º C +/- (b)(4) º C ((b)(4) º F +/- (b)(4) º F), and a minimum pasteurization temperature parameter of (b)(4) º C ((b)(4) º F), which does not ensure that you achieve the filed processing temperature in your scheduled process.

Your written response stated you have revised your Hazard Analysis Critical Control Point (HACCP) plan, will contact your US agent to update processing data for products registered with the FDA, and will provide evidence of corrective actions once your vegetable processing season begins. However, to date, we have not received any new filings, or requests to change processing parameters for the currently filed scheduled process of your yellow pepper fillets, packaged into container sizes of (b)(4) * (b)(4) ((b)(4) oz). In addition, during the inspection our investigator identified that the shelf-life of your yellow pepper fillet products is (b)(4) years. However, your response does not identify that the products associated with above-mentioned process deviations have undergone processes that rendered them safe. On March 27, 2024, we replied to your February 13, 2024, email response requesting additional information and inquiring if deviations observed during the inspection were reviewed by a process authority, underwent an evaluation that demonstrates the affected products had undergone a process that renders them safe, or any other corrective actions, as applicable. On April 16, 2024, you responded providing an updated English version of your HACCP plan, current corrective actions, and also identified that products had undergone a process that renders them safe. However, as required by 21 CFR 114.89, whenever any process operation deviates from the scheduled process for any acidified food, the commercial processor of the acidified food shall either: (a) Fully reprocess that portion of the food by a process established by a competent processing authority as adequate to ensure a safe product; (b) thermally process it as a low-acid food; or (c) set aside that portion of the food involved for further evaluation as to any potential public health significance.

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, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with acidified food regulations (21 CFR 108 and 114), is Import Alert #99-38, Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods Due to Inadequate Process Controls. This alert can be found on FDA's web site at 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 [Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108)], the Acidified Foods regulation (21 CFR Part 114), and the current Good Manufacturing Practice regulation (21 CFR Part 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 # 682450 on any submissions and within the subject line of any emails to us.

Sincerely,
/S/

Amy Barringer for
Ann M. Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition