As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
The FDA has issued warning letters to three food processing companies — Chongqing Tianrun Food Development Co. Ltd. in China, Baldwin Richardson Foods Pennsauken LLC in New Jersey, and Dalai Biotech Company Ltd. in Taiwan — for significant violations of federal food safety regulations. These violations, identified during inspections in 2024, raise concerns about potential health hazards, including botulism and microbial contamination in low-acid canned foods (LACF) and acidified food products.
Chongqing Tianrun Food Development Co. Ltd.
Chongqing, China
The FDA issued a warning letter on Oct. 22, 2024, to Chongqing Tianrun Food Development Co., Ltd., a low-acid canned food (LACF) processor, following an inspection from April 17 to 19, 2024, at its facility in Chongqing, China. The inspection revealed serious deviations from the Emergency Permit Control regulation (21 CFR Part 108) and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR Part 113), rendering the company’s 230g pouches of roasted gluten and other LACF tofu products adulterated under the Federal Food, Drug, and Cosmetic Act.
Critical violations:
- Failure to register as a Food Canning Establishment (FCE): The company did not register as an FCE before shipping LACF tofu products to the U.S. between July 2023 and April 2024. Although the company registered on May 30, 2024, it had already exported products without compliance.
- Unfiled scheduled processes: The company failed to file scheduled processes for its LACF tofu products, such as QQ Dried Beans, as required. Filed processes in June and July 2024 did not match container sizes shipped to the United States, and heat distribution studies were incomplete.
- Unqualified process authority: The scheduled processes were not established by a qualified person with expertise in thermal processing, as required. Heat distribution studies for retorts were either missing or conducted for different container sizes.
- Inadequate monitoring of critical factors: The company did not measure or record critical factors like initial temperature, fill weight, or processing pressure. Consumer complaints about swollen vacuum packages indicated potential under-processing, with no investigation conducted.
- Water level and retort maintenance issues: Operators did not check or record water levels during processing, and retorts showed residue buildup and obstructions.
- Inadequate hermetic seal checks: The company failed to maintain records of pouch closure inspections, with consumer complaints noting leaking bags due to poor seals.
- Lack of Trained Personnel: No staff had received FDA-approved training for LACF processing.
FDA action and next steps
The company’s April 30, 2024, response promised corrective actions, including FCE registration, process filing, and equipment upgrades, but lacked supporting documentation. Failure to comply could lead to refusal of product entry into the U.S. and placement on Import Alert #99-38, allowing detention without physical examination.
The full warning letter can be viewed here.
Baldwin Richardson Foods Pennsauken LLC
Pennsauken, NJ
The FDA issued a warning letter on Dec. 26, 2024, to Baldwin Richardson Foods Pennsauken LLC, following an inspection from July 15 to Aug. 23, 2024, at its aseptic processing facility in Pennsauken, NJ. The inspection identified serious violations of the Emergency Permit Control regulation (21 CFR Part 108) and the Thermally Processed Low-Acid Foods regulation (21 CFR Part 113), rendering its non-dairy LACF beverages, such as Califia Toasted Coconut Almond Milk, adulterated.
Critical violations:
- Inadequate deviation handling: On May 17, 2024, a lot of Califia Toasted Coconut Almond Milk showed microbiological growth, but the company did not follow its process authority’s recommended stress testing protocol. Additionally, temperature deviations in drying air were not identified as process deviations.
- Incomplete production records: Critical factors like sterilization times and steam seal performance were not recorded in production records. Products were routinely shipped before record review, including pH and incubation results.
- Container integrity failures: The company failed to document corrective actions for container integrity check failures, such as torque values, and gaps in monitoring exceeded the required 30-minute intervals.
- Unmonitored steam seals: Steam seal performance downstream of the hold tube was not monitored or recorded.
FDA action and next steps
The company’s Sept. 22, 2024, response outlined planned corrective actions, including updated deviation procedures and record-keeping, but lacked supporting documentation. Failure to correct violations could result in regulatory action, including seizure or injunction.
The full warning letter can be viewed here.
Dalai Biotech Company Ltd.
Tongluo Township, Taiwan
The FDA issued a warning letter on Sept. 30, 2024, to Dalai Biotech Company Ltd, following an inspection from May 24 to 27, 2024, at its acidified food facility in Tongluo Township, Taiwan. The inspection revealed significant deviations from the Emergency Permit Control regulation (21 CFR Part 108) and the Acidified Foods regulation (21 CFR Part 114), rendering its fruit-flavored popping boba pearls adulterated.
Critical violations:
- Failure to register as an FCE: The company did not register as an FCE before shipping acidified boba pearls to the U.S. It continued shipments as recently as Sept. 6, 2024, without registering.
- Unfiled scheduled processes and unqualified process authority: No scheduled processes were filed for boba pearls, and processes were not established by a qualified person. The company lacked written recipes and routine pH testing, with a random test showing a pH of (redacted by FDA) for mango-flavored boba pearls.
FDA action and next steps
The company’s June 11, 2024, response promised HACCP training and third-party certification but provided no evidence of completion or filed processes. Failure to comply could lead to refusal of product entry and placement on Import Alert #99-37 or #99-38.
The full warning letter can be viewed here.
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