# FDA 483 - Golden Lab LLC - February 21, 2023

Source: https://www.keypedia.com/records/483/golden-lab-llc/5cf73921-310c-4517-9ad5-3d1ccc1636d2

> FDA 483 for Golden Lab LLC on February 21, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Golden Lab LLC
- Inspection Date: 2023-02-21
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Golden Lab LLC, a dietary supplement manufacturer in Jacksonville, FL, was cited for two observations during an FDA inspection. The firm failed to establish and maintain adequate specifications and acceptance criteria for finished product testing, and did not ensure that test methods used by its contract testing laboratory were appropriate and scientifically valid. These issues led to the release of products without proper quality evaluation.

## Related Documents

- [WARNING_LETTER - 2021-11-10](https://www.keypedia.com/records/warning_letter/golden-lab-llc/60c82eaf-9f07-4697-baef-cb968e96c59a)

## Related Officers

- [Donald J. Mee](https://www.keypedia.com/people/donald-j-mee/9389c8ef-3635-4d15-baf2-1f91b640f963)
- [David P. King](https://www.keypedia.com/people/david-p-king/b420ffcd-5ae1-40d3-a72a-5ac41bdba0eb)
- [Ivis L. Negron Torres](https://www.keypedia.com/people/ivis-l-negron-torres/eb77f360-bb0b-4a13-a0da-b89c36ccaca9)

Company: https://www.keypedia.com/companies/golden-lab-llc/21cd97c6-9b3b-4576-8744-1128542d68ca

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6