# FDA 483 - Lex, Inc. - February 28, 2023

Source: https://www.keypedia.com/records/483/lex-inc/85bece66-fe44-4c99-878d-421e16e8dffb

> FDA 483 for Lex, Inc. on February 28, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lex, Inc.
- Inspection Date: 2023-02-28
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Lex Inc. DBA Lex Pharmaceutical in Medley, FL, was cited for significant deficiencies in its manufacturing of OTC drugs and dietary supplements. The inspection revealed widespread issues including inadequate raw material testing, lack of process validation, and poor quality control practices. Many of these observations were repeats from prior FDA inspections, indicating a persistent failure to implement corrective actions.

## Related Documents

- [483 - 2018-02-14](https://www.keypedia.com/records/483/lex-inc/8e773945-fc6e-49f7-a50d-c7a3b0575c4f)

## Related Officers

- [Benita C. Okeke](https://www.keypedia.com/people/benita-c-okeke/1c62b9fb-4cc6-4d6b-966c-98b471d850e4)
- [Suzanne N. Vallez](https://www.keypedia.com/people/suzanne-n-vallez/7c16e0f4-c0b1-4f50-adfa-b1dc534694cd)
- [Investigator ](https://www.keypedia.com/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

Company: https://www.keypedia.com/companies/lex-inc/9cd91df7-e83b-48c0-8aad-de1843c37ade

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