FDA WARNING_LETTER - Baldwin Richardson Foods Pennsauken, LLC - August 23, 2024

The FDA inspected Baldwin Richardson Foods Pennsauken, LLC's aseptic processing facility for low-acid canned food (LACF) non-dairy beverages from July 15 to August 23, 2024. The inspection revealed serious violations of 21 CFR Part 108 (Emergency Permit Control) and 21 CFR Part 113 (Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers). These violations render the LACF products adulterated under section 402(a)(4) of the Act.

Key violations include: 1. **Failure to evaluate deviations from scheduled processes (21 CFR 113.89):** The firm failed to adequately evaluate a process deviation for Califia Toasted Coconut Almond Milk, lot (b)(4), which showed microbiological growth. The process authority's evaluation did not address the microbial findings or inconsistencies in pH testing and sampling. Additionally, temperature deviations for the (b)(4) Drying Air Temperature, a critical factor, were not identified as process deviations. The firm's response regarding reviewing its deviation system and resetting equipment was noted, but a revised procedure or process authority evaluation for the temperature deviation was not provided.

2. **Inadequate processing and production records (21 CFR 113.100(b)):** Official production records lacked documentation of critical factors and explanations for deviations. The monitoring software lacked set