# FDA 483 - Design Specific, Ltd. - February 07, 2019

Source: https://www.globalkeysolutions.net/records/483/design-specific-ltd/ba29fa42-ac2e-4232-bf72-149e5d1f344e

> FDA 483 for Design Specific, Ltd. on February 07, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Design Specific, Ltd.
- Inspection Date: 2019-02-07
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Design Specific, Ltd., a medical device manufacturer in Laughton, revealed significant deficiencies in its quality system. The firm failed to establish or adequately implement procedures for design changes, purchasing and receiving, device history records, employee training, and internal quality audits. These issues indicate a systemic lack of control over critical manufacturing and quality assurance processes.

## Related Officers

- [Eric C. Fox](https://www.globalkeysolutions.net/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)

Company: https://www.globalkeysolutions.net/companies/design-specific-ltd/1ca116e2-f2f0-4ae9-843e-ce807cea016a

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd