FDA WARNING_LETTER - Ruby's Quail Farm - May 21, 2015

On May 14-21, 2015, the FDA inspected Ruby's Quail Farm, an acidified food manufacturer, and found serious violations of 21 CFR Part 108 (Emergency Permit Control) and Part 114 (Acidified Foods). These violations render their products, including Hot and Mild Pickled Quail Eggs, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to file scheduled processes:** The firm failed to provide FDA-accepted scheduled processes for Hot and Mild Pickled Quail Eggs in (b)(4) glass jars, despite manufacturing these products since (b)(4). An initial submission was incomplete and returned. (21 CFR 108.25(c)(2)) 2. **Failure to follow scheduled process:** The firm did not adhere to its scheduled process for Hot and Mild Pickled Quail Eggs, specifically failing to verify and record the correct process (b)(4) temperature. For example, batch records showed temperatures below the minimum scheduled process temperature. (21 CFR 114.80(a)(1)) 3. **Failure to maintain adequate processing records:** Batch records lacked equilibrium pH test results, (b)(4) temperature of thermal process, and process time of the (b)(4) temperature for various batches. (21 CFR