# FDA 483 - Lexamed, Ltd - December 06, 2018

Source: https://www.globalkeysolutions.net/records/483/lexamed-ltd/b6149be9-f1da-47a4-8d44-e0f23ccf3499

> FDA 483 for Lexamed, Ltd on December 06, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lexamed, Ltd
- Inspection Date: 2018-12-06
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: LexaMed, Ltd, a contract testing laboratory in Toledo, OH, received a Form 483 for deficiencies in its laboratory control systems. The inspection revealed inadequate environmental monitoring sampling plans for microbiological bioburden testing and a failure to document sample storage conditions and locations. These issues indicate a lack of robust controls to ensure the quality and purity of drug products.

## Related Documents

- [483 - 2022-04-08](https://www.globalkeysolutions.net/records/483/lexamed-ltd/0b6899dc-7b2f-4531-bdcf-ee0aec35e095)
- [483 - 2022-08-04](https://www.globalkeysolutions.net/records/483/lexamed-ltd/483c4a3f-941d-4099-8ae1-47325642536a)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/sarah-e-rhoades/d965990c-15cc-4722-b2d0-aea7206c71b0)

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

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