FDA WARNING_LETTER - Constanza Agroindustrial, S.R.I. - December 04, 2012

The FDA inspected Constanza Agroindustrial, S.R.I. in the Dominican Republic on December 3-4, 2012, uncovering serious deviations from the acidified foods regulation (21 CFR Part 114). An FDA-483 was issued. Key violations included the firm's failure to manufacture acidified food, specifically Garlic Paste Constanza, according to its scheduled process (21 CFR 114.80(a)(1)), citing issues with hot fill temperature, jar inversion, and unauthorized ingredient substitution. A required new process filing (21 CFR 108.25(c)(2)) for these changes was not submitted. The firm also failed to adequately control and test to ensure the finished equilibrium pH was not above 4.6 (21 CFR 114.80(a)(2)), lacking studies on pH changes post-capping. Furthermore, processing records were incomplete, with inadequate monitoring of internal temperatures (21 CFR 114.100(b)). The firm's April 2013 response acknowledged GMP corrections but did not include the new process filing. Non-compliance renders products adulterated (21 U.S.C. 342(a)(4)) and can lead to refusal of admission under Section 801 of the Act, including detention without physical examination (DWPE) via Import Alert #99-04. The firm must respond within 15 working days, detailing corrective actions and providing documentation, or face further regulatory action and potential reinspection fees.