# FDA 483 - Bio Lab Naturals, Inc - April 13, 2023

Source: https://www.keypedia.com/records/483/bio-lab-naturals-inc/2d74bd93-6843-4c28-8886-34db5185dc22

> FDA 483 for Bio Lab Naturals, Inc on April 13, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bio Lab Naturals, Inc
- Inspection Date: 2023-04-13
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Pure Solutions Inc. in Tampa, FL, revealed 10 significant deficiencies in their manufacturing of dietary supplements. The observations primarily highlight systemic failures in quality control, lack of established specifications for components and finished products, inadequate record-keeping, and poor facility maintenance. These issues collectively indicate a substantial deviation from good manufacturing practices, posing potential risks to product quality and safety.

## Related Officers

- [David P. King](https://www.keypedia.com/people/david-p-king/b420ffcd-5ae1-40d3-a72a-5ac41bdba0eb)
- [Megan K. Otero](https://www.keypedia.com/people/megan-k-otero/bac65e8e-6e3f-4547-8627-5fb299853eb6)

Company: https://www.keypedia.com/companies/bio-lab-naturals-inc/1e76c3e3-8e24-4db6-866b-60a6a6f2b517

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