# FDA 483 - Euclid Systems Corporation - March 07, 2018

Source: https://www.keypedia.com/records/483/euclid-systems-corporation/feba8449-58e7-447b-9f6f-d5c9e574c5f6

> FDA 483 for Euclid Systems Corporation on March 07, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Euclid Systems Corporation
- Inspection Date: 2018-03-07
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Euclid Systems Corporation, a contact lens manufacturer in Sterling, VA, revealed significant deficiencies across its quality system. The firm was cited for inadequate validation of manufacturing processes, poorly established corrective and preventive action procedures, and insufficient vendor evaluation. Additionally, issues were found with equipment calibration and maintenance documentation, indicating a broad lack of control over critical operations.

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## Related Officers

- [investigator](https://www.keypedia.com/people/james-m-simpson/3c0113ae-d846-4e37-aafa-13d58c465fa3)

Company: https://www.keypedia.com/companies/euclid-systems-corporation/9056f871-1da6-4163-8f5f-62f17fe343b5

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e