Tamara Fruit CJSC – FDA Warning Letter, Feb 14, 2024

The FDA conducted an inspection of Tamara Fruit CJSC in Armenia from February 12-14, 2024, identifying serious deviations in the manufacturing of juice-based nectars and acidified foods. The inspection revealed violations of the Juice Hazard Analysis and Critical Control Point (HACCP) Systems regulation (21 CFR 120), Emergency Permit Control regulation (21 CFR 108), and Acidified Foods regulation (21 CFR 114). An FDA-483 was issued, but no response was received, leading to the determination that the firm's products are adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Specific violations include the failure to list all reasonably likely food hazards in the HACCP plan (21 CFR 120.8(b)(1)) and the lack of sanitation standard operating procedure records (21 CFR 120.6(c)). For acidified foods, the firm failed to maintain processing and production records showing adherence to the scheduled process (21 CFR 114.100(b)) and did not mark containers with identifying codes (21 CFR 114.80(b)). Tamara Fruit CJSC must respond in writing within fifteen working days, detailing specific corrective actions with supporting documentation. Failure to adequately respond or correct deficiencies may result in refusal of admission for imported products and placement on Detention Without Physical Examination (DWPE) under relevant Import Alerts.