FDA WARNING_LETTER - Dallas Calco, Inc - August 15, 2012

On August 8-15, 2012, the FDA inspected Dallas Calco, Inc.'s food processing facility in Dallas, TX, and found serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These violations render the firm's food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions. The firm has not responded to the FDA-483 issued on August 15, 2012.

Key violations include: 1. **Failure to minimize microbial growth (21 CFR 110.80(b)(2)):** Lack of monitoring for soybean slurry cook temperature/time, improper storage temperatures for in-process dry pressed tofu (48°C in cooler, 63°F during packing, surface temps up to 58°F), and non-operational thermometers for in-process and finished product coolers. 2. **Insanitary conditions (Section 402(a)(4) of the Act):** Observed in the mung bean sprouting room: a box fan with black dust blowing onto ready-to-eat sprouts, cracked plastic side panels of sprouting bins difficult to clean, disrepaired and rough concrete floor with standing water, a coiled hose stored on the wet floor without