# FDA 483 - Lexamed, Ltd - August 04, 2022

Source: https://www.globalkeysolutions.net/records/483/lexamed-ltd/483c4a3f-941d-4099-8ae1-47325642536a

> FDA 483 for Lexamed, Ltd on August 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lexamed, Ltd
- Inspection Date: 2022-08-04
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Lexamed, Ltd in Toledo, OH, a control testing laboratory, revealed two significant observations. The firm was cited for failing to maintain equipment to prevent contamination, specifically a damaged HEPA Laminar Flow Hood. Additionally, Lexamed, Ltd did not follow established documentation practices, including issues with repeat analysis records, outdated procedures, and unexplained log book entries.

## Related Documents

- [483 - 2018-12-06](https://www.globalkeysolutions.net/records/483/lexamed-ltd/b6149be9-f1da-47a4-8d44-e0f23ccf3499)
- [483 - 2022-04-08](https://www.globalkeysolutions.net/records/483/lexamed-ltd/0b6899dc-7b2f-4531-bdcf-ee0aec35e095)

## Related Officers

- [Joohi Castelvetere](https://www.globalkeysolutions.net/people/joohi-castelvetere/2340bef8-5105-4f40-9713-120196b70d82)
- [Andrew J. Barrowcliff](https://www.globalkeysolutions.net/people/andrew-j-barrowcliff/5dd49407-9028-4c84-9e86-3f0b6239538e)

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

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