# FDA 483 - Vesta Pharmaceuticals, Inc. - February 09, 2024

Source: https://www.keypedia.com/records/483/vesta-pharmaceuticals-inc/7b2d68d8-c501-447c-9bd7-7e5a9ae8e89e

> FDA 483 for Vesta Pharmaceuticals, Inc. on February 09, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vesta Pharmaceuticals, Inc.
- Inspection Date: 2024-02-09
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Vesta Pharmaceuticals, Inc. in Indianapolis, IN, a dietary supplement manufacturer, revealed significant deficiencies in quality control and material management. Observations included incomplete batch production records, unverified instrument calibration logs, and improper storage of quarantined and expired materials. These issues indicate a lack of adequate controls over manufacturing processes and product integrity.

## Related Officers

- [John N. Woodall](https://www.keypedia.com/people/john-n-woodall/60ba74fb-65b8-4195-a8bd-a9b576108246)
- [Vera M. Anderson](https://www.keypedia.com/people/vera-m-anderson/6e5f6641-6099-451d-aeca-31a0b0875cfc)
- [Consumer Safety Officer](https://www.keypedia.com/people/jennifer-r-johnson/9387dded-fe17-4af1-aa0f-62e6b5c560e7)

Company: https://www.keypedia.com/companies/vesta-pharmaceuticals-inc/902b5f9f-2c1f-4806-8cdc-f9cb92ff5299

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0