FDA WARNING_LETTER - Advance Nature Sdn Bhd - March 14, 2024

The FDA inspected Lot 88, Perindustrian Senawang, a low-acid canned food (LACF) facility in Malaysia, from March 12-14, 2024, finding serious deviations from 21 CFR 113 (Thermally Processed Low-Acid Foods) and 21 CFR 108 (Emergency Permit Control). The firm aseptically packages low-acid bamnut milk.

Key violations include: 1. Failure to provide evidence that scheduled processes were established by a qualified person with expert knowledge in thermal processing (21 CFR 113.83). The firm's business director, lacking LACF training, submitted processes for bamnut milk, a legume-based product, using milk product sterilization parameters without process authority evaluation. 2. Failure to identify when processes deviated from the scheduled process (21 CFR 113.89). Records showed UHT processing temperatures for "Bamnut Milk" were below the filed (b)(4)°C, as low as (b)(4)°C, for multiple hourly recordings on July 5, 2023, without process authority evaluation. 3. Failure to record processing and production information for the aseptic system at the time of observation (21 CFR 113.100(a)(4)). The "UHT Daily Operation Record" only recorded outlet temperature once per hour