# FDA 483 - Bumble Bee Foods, LLC. - October 24, 2024

Source: https://www.keypedia.com/records/483/bumble-bee-foods-llc/b6b437f6-0444-4c26-8da6-67fdd2e79028

> FDA 483 for Bumble Bee Foods, LLC. on October 24, 2024. Product: Dietary Supplements. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bumble Bee Foods, LLC.
- Inspection Date: 2024-10-24
- Product Type: Dietary Supplements
- Office Name: Atlanta District Office
- Summary: Valentine Enterprises, Inc., a dietary supplement manufacturer located in Lawrenceville, GA, underwent an FDA inspection from October 8 to October 24, 2024. The inspection revealed several significant compliance issues primarily related to product specifications and quality control processes.

Key violations included the failure to establish comprehensive product specifications for identity, purity, strength, composition, and contamination limits for their dietary supplements. The firm's existing "Finished Product Specification Formulation" lacked scientifically valid methods and acceptance criteria to confirm these specifications. Notably, only a limited number of components were tested, and the methods used were not scientifically validated.

Additionally, Valentine Enterprises did not establish identity specifications or necessary purity, strength, and contamination limits for components used in their products. The firm relied on suppliers' Certificates of Analysis without creating firm-specific specifications, which is inadequate for ensuring product quality.

The inspection also highlighted that a batch of dietary supplements was approved and released without being manufactured, packaged, labeled, or held under conditions that prevent adulteration. Furthermore, the microbiological testing procedures were insufficient, as they did not differentiate between pathogenic and non-pathogenic strains, potentially allowing harmful bacteria to pass quality checks.

The FDA requires Valentine Enterprises to address these issues by establishing scientifically valid specifications and testing methods, implementing robust quality control measures, and ensuring all products are manufactured under conditions that prevent adulteration. The firm is encouraged to discuss objections or corrective actions with the FDA and submit any relevant information to the agency.

## Related Officers

- [Sandra R. Saunders](https://www.keypedia.com/people/sandra-r-saunders/3bc09d03-02f6-4287-bc01-6cc451eaecb7)
- [Gary C. Pecic](https://www.keypedia.com/people/gary-c-pecic/37cf1f4d-6b1c-4be6-8adb-89cf685f5022)
- [Stephanie L. Kelly](https://www.keypedia.com/people/stephanie-l-kelly/d0b0409f-85a2-457c-b955-38fc399cf21f)

Company: https://www.keypedia.com/companies/bumble-bee-foods-llc/f92efad6-9797-46f5-917f-131ccb1fe63b

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7