# FDA 483 - Validation Systems Inc - April 13, 2017

Source: https://www.keypedia.com/records/483/validation-systems-inc/d9b48a2a-e4e7-45e9-b71f-6b6f3872bbf3

> FDA 483 for Validation Systems Inc on April 13, 2017. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Validation Systems Inc
- Inspection Date: 2017-04-13
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Validation Systems Inc, a contract laboratory in Palo Alto, CA, was cited for significant deficiencies across multiple quality system areas. The inspection revealed inadequate environmental monitoring in aseptic processing, a failure to investigate unexplained discrepancies, and issues with cleaning procedures, microbiological contamination prevention, and adherence to production controls. The firm also demonstrated a lack of quality unit oversight in component approval.

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)
- [Ashar P. Parikh](https://www.keypedia.com/people/ashar-p-parikh/f5430c51-31c7-44bb-90f7-1ec8ae581343)
- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

Company: https://www.keypedia.com/companies/validation-systems-inc/bbcad82c-2696-4134-848c-e0029f20ba49

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b