# FDA 483 - Braga Fresh Foods LLC - November 07, 2023

Source: https://www.keypedia.com/records/483/braga-fresh-foods-llc/126da826-03af-4720-bd0c-a5c58abb87bc

> FDA 483 for Braga Fresh Foods LLC on November 07, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Braga Fresh Foods LLC
- Inspection Date: 2023-11-07
- Product Type: other
- Office Name: San Francisco District Office
- Summary: Braga Fresh Foods LLC received an FDA Form 483 following an inspection conducted from October 24 to November 7, 2023. The inspection identified three significant observations related to the company's food safety management system, particularly concerning allergen controls.The first observation noted that Braga Fresh Foods failed to reanalyze its food safety plan after two separate recall events in July and October 2023. These recalls involved salad kits containing undeclared milk and eggs, identified as serious adverse health consequences hazards, resulting from human error during packaging and ingredient transfer. Although some corrective actions were initiated for the packaging error, a full reassessment of the undeclared allergen hazard was not conducted.Secondly, the FDA found that the company's written allergen preventive control procedures at the packaging step were inadequate. Deficiencies included insufficient monitoring, verification, and corrective action protocols. Specific issues highlighted were incomplete documentation for ingredient handling, lack of written procedures for transferring allergen-containing components, unclear labeling of ingredient storage containers, and inadequate frequency of checks for ingredient-to-packaging matching, especially considering high production rates.Finally, the inspection revealed that Braga Fresh Foods' hazard analysis did not identify the rework step as requiring a preventive control for undeclared allergens. This is critical because various allergen-containing ingredients are separated from finished products for rework and returned to storage during the same production shift, posing a cross-contamination risk.Braga Fresh Foods LLC must address these observations to ensure compliance with food safety regulations, particularly by strengthening its food safety plan reanalysis, enhancing allergen preventive controls, and updating its hazard analysis to cover all relevant steps.

## Related Documents

- [483 - 2023-11-07](https://www.keypedia.com/records/483/braga-fresh-foods-llc/5827a0ef-6b39-4de4-bafd-79753e7606d5)

## Related Officers

- [Kacie M Crowther, Investigator](https://www.keypedia.com/people/kacie-m-crowther-investigator/f166782d-b0eb-41fa-badc-7b528c5a6cad)

Company: https://www.keypedia.com/companies/braga-fresh-foods-llc/22bda2a3-0c5b-40d8-9447-3f03aa873ec8

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df