# FDA 483 - Litron Laboratories, LTD - June 02, 2009

Source: https://www.globalkeysolutions.net/records/483/litron-laboratories-ltd/1481190c-1d3c-447b-91f1-3d56d687e9c3

> FDA 483 for Litron Laboratories, LTD on June 02, 2009. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Litron Laboratories, LTD
- Inspection Date: 2009-06-02
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Litron Laboratories, LTD in Rochester, NY, a non-clinical laboratory, was cited with two observations during an FDA inspection. The inspection revealed failures within the Quality Assurance Unit, specifically regarding inadequate inspection intervals for high-risk study steps and a lack of independence between QAU personnel and study direction. These issues indicate deficiencies in ensuring the integrity and oversight of nonclinical laboratory studies.

## Related Officers

- [Harry J. Brewer](https://www.globalkeysolutions.net/people/harry-j-brewer/d9e4de87-ec9c-4807-8afb-e9b1a731e893)

Company: https://www.globalkeysolutions.net/companies/litron-laboratories-ltd/65d65714-6ff4-4f8c-93fb-708ff70862b2

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961