# Lexamed, Ltd – FDA 483, Jul 9, 2026

Source: https://www.keypedia.com/records/483/lexamed-ltd/abe80665-9b6f-4447-ae3d-6308fc635e48

> FDA 483 for Lexamed, Ltd on July 09, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lexamed, Ltd
- Inspection Date: 2026-07-09
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Lexamed, Ltd in Toledo, OH, a contract laboratory, revealed significant deficiencies in laboratory controls and quality assurance. The firm failed to establish scientifically sound procedures for media preparation and sterility testing, leading to inconsistent and potentially unreliable results. Additionally, Lexamed did not thoroughly investigate microbial growth or visual anomalies in culture media and lacked defined hold times for sterilized equipment, raising concerns about product quality and safety.

## Related Documents

- [483 - 2022-08-04](https://www.keypedia.com/records/483/lexamed-ltd/483c4a3f-941d-4099-8ae1-47325642536a) — date: August 4, 2022
- [483 - 2022-04-08](https://www.keypedia.com/records/483/lexamed-ltd/0b6899dc-7b2f-4531-bdcf-ee0aec35e095) — date: April 8, 2022
- [483 - 2018-12-06](https://www.keypedia.com/records/483/lexamed-ltd/b6149be9-f1da-47a4-8d44-e0f23ccf3499) — date: December 6, 2018

## Related Officers

- [Anna M. Spiros](https://www.keypedia.com/people/anna-m-spiros/13e6a69c-d3d5-431c-9895-0df9b86691b7)
- [Kara J. Wright](https://www.keypedia.com/people/kara-j-wright/d12b6a4f-9710-4811-b1b2-5ff5f9342155)

Company: https://www.keypedia.com/companies/lexamed-ltd/b54f148c-75ae-4ec5-aee3-d675b90f3f88

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22