FDA WARNING_LETTER - Swity d.o.o. - January 23, 2024

The FDA conducted an inspection of Sarajevska Ulica's acidified foods processing facility in Bosnia-Hercegovina on January 22-23, 2024, revealing serious violations of the Emergency Permit Control (21 CFR Part 108) and Acidified Foods (21 CFR Part 114) regulations. An FDA-483 was issued, and the firm's subsequent responses on February 13 and April 16, 2024, were deemed inadequate. The primary violation identified was the firm's failure to process yellow pepper fillet products in conformity with its scheduled process filed with the FDA, as required by 21 CFR 108.25(c)(3)(i). This included not monitoring critical parameters like finished product pH and maximum fill weight, processing for insufficient time, and at lower temperatures than specified in the scheduled process. Additionally, the firm failed to properly handle deviations from the scheduled process for acidified foods, as mandated by 21 CFR 114.89, which requires reprocessing, thermal processing as a low-acid food, or setting aside the affected food for evaluation. These violations render the firm's acidified yellow pepper fillet products adulterated under section 402(a)(4) of the Act. The FDA requires a written response within fifteen working days outlining specific corrective actions, including supporting documentation like processing records for five product lots. Failure to adequately respond may result in refusal of admission for imported products under section 801(a) of the Act, including detention without physical examination (DWPE) via Import Alerts.