# FDA 483 - Lex, Inc. - February 14, 2018

Source: https://www.globalkeysolutions.net/records/483/lex-inc/8e773945-fc6e-49f7-a50d-c7a3b0575c4f

> FDA 483 for Lex, Inc. on February 14, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Lex, Inc.
- Inspection Date: 2018-02-14
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Lex, Inc., a drug manufacturer in Medley, FL, was cited with seven observations during an FDA inspection from January 30 to February 14, 2018. The inspection revealed significant deficiencies in quality control, laboratory practices, and manufacturing processes. Key issues included inadequate investigations into out-of-specification results, failure to follow stability testing programs, incomplete laboratory records, and a lack of process validation and equipment qualification.

## Related Documents

- [483 - 2023-02-28](https://www.globalkeysolutions.net/records/483/lex-inc/85bece66-fe44-4c99-878d-421e16e8dffb)

## Related Officers

- [Saundra A. Munroe](https://www.globalkeysolutions.net/people/saundra-a-munroe/8e9b8973-5ac4-4a2a-ab26-1618c0e434e7)
- [Jennifer L. Huntington](https://www.globalkeysolutions.net/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)

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

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