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 recently issued warning letters to three companies — Ya Ya Foods USA LLC, Alfred Louie Inc., and Bernardo Farms LLC — highlighting significant lapses in food safety and regulatory compliance.
Ya Ya Foods USA LLC
Ogden, UT
Ya Ya Foods was cited on Sept. 24 for several regulatory violations at its low-acid canned food (LACF) facility, where Oatly oat milk products are processed.
At the conclusion of the May 13-16 inspection of the firm’s LACF facility, FDA investigators issued a Form FDA 483 (FDA-483), Inspectional Observations.
Key issues included failure to monitor critical sterilization temperatures, inadequate recording procedures for aseptic processes, and deviations from scheduled processing controls. These oversights in monitoring, steam supply, and documentation put product sterility at risk, raising concerns about potential contamination.
FDA findings:
Lack of adequate temperature control in steam barriers.
Incomplete monitoring records for aseptic conditions.
Insufficient verification of sterilization processes.
The full warning letter can be viewed here.
Alfred Louie Inc.
Bakersfield, CA
On Sept. 11 the FDA warned Alfred Louie Inc., a noodle and sprouting manufacturer, about critical food safety failures, especially concerning allergen management and mislabeling.
At the conclusion of the Jan. 2 through Feb. 20 inspection of the firm’s sprouting operation and noodle manufacturing facility, the FDA issued an FDA Form 483, Inspectional Observations, listing the deviations found at their facility.
The FDA noted that the company failed to declare allergens, such as wheat, on labels and did not implement preventive controls for allergens. Additionally, the company’s labeling lacked essential ingredient details and correct allergen declarations, resulting in misbranded products and a recall of improperly labeled noodles.
FDA findings:
Absence of controls for allergen cross-contact and labeling.
Failure to evaluate hazards like mycotoxins and metal contamination.
Labels lacking major allergen declarations and accurate ingredient lists.
The full warning letter can be viewed here.
Bernardo Farms LLC
Pahoa, HI
Bernardo Farms, a papaya grower, received a warning on Sept. 25 following an inspection that found inadequate sanitation and safety measures.
Violations included the absence of nearby restroom facilities for employees, contaminated harvest tools, and lack of training records. Inspectors also observed unsanitary practices, with employees lacking adequate restroom access and papayas being packed on soiled surfaces.
FDA findings:
No accessible restroom facilities near growing fields.
Unsanitary handling practices, including dirty harvest tools.
Failure to maintain training and sanitation documentation.
The FDA’s letters highlight its commitment to enforcing food safety regulations under the Food Safety Modernization Act (FSMA). Non-compliance could lead to severe consequences, including product recalls and restrictions on distribution if corrective actions aren’t take.
The full warning letter can be viewed here.
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