# FDA 483 - Pharma Tech Solutions, Inc - January 15, 2020

Source: https://www.keypedia.com/records/483/pharma-tech-solutions-inc/103388bf-3d33-470e-8f32-8d57085423a8

> FDA 483 for Pharma Tech Solutions, Inc on January 15, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Pharma Tech Solutions, Inc
- Inspection Date: 2020-01-15
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Pharma Tech Solutions, Inc., a medical device manufacturer in Westlake Village, CA, was inspected by the FDA. The inspection revealed a significant issue related to the documentation of design review results in the design history file. This indicates a deficiency in their quality system for medical device design control.

## Related Documents

- [WARNING_LETTER - 2014-03-06](https://www.keypedia.com/records/warning_letter/pharma-tech-solutions-inc/daf88dc3-2beb-47eb-b1f4-a3b0fb448b63)

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.keypedia.com/companies/pharma-tech-solutions-inc/968592e8-6bc7-496c-9249-03959cf736be

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6