FDA WARNING_LETTER - Desert Premium Group, LLC - September 28, 2020
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The FDA inspected an acidified food manufacturing facility in Albuquerque, New Mexico, from September 22-28, 2020, finding serious deviations from Emergency Permit Control (21 CFR 108) and Acidified Foods (21 CFR 114) regulations. The firm's salsas and sauces were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.
Key violations include: 1. **Failure to manufacture in accordance with scheduled processes (21 CFR 114.80(a)(1)):** The firm failed to file updated scheduled processes with the FDA for products like Hatch Valley Flame Roasted Green Chile (72 oz. plastic jugs) and Trader Joe’s brand Hatch Valley Salsa (12 oz. glass jars). The critical parameters currently used in production, based on a December 2019 process authority letter, differ from those filed with the FDA in 2016 and 2017, respectively. This is a systemic issue, as the firm was cited for similar violations in 2014, 2016, and 2017. 2. **Failure to handle process deviations (21 CFR 114.89):** * Hatch Valley Salsa (Lot D040620) had an equilibrium
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