# FDA 483 - EXACT MEDICAL MANUFACTURING - May 02, 2019

Source: https://www.globalkeysolutions.net/records/483/exact-medical-manufacturing/692eece4-36d7-4f8f-84a0-82b277c8c312

> FDA 483 for EXACT MEDICAL MANUFACTURING on May 02, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: EXACT MEDICAL MANUFACTURING
- Inspection Date: 2019-05-02
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: EXACT MEDICAL MANUFACTURING in Changzhou, China, was inspected by the FDA from April 29 to May 2, 2019. The inspection revealed significant deficiencies in process validation, equipment calibration, and document control. These issues indicate a lack of adequate quality system procedures for manufacturing medical devices.

## Related Officers

- [Gamal A. Norton](https://www.globalkeysolutions.net/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.globalkeysolutions.net/companies/exact-medical-manufacturing/ca8c3f62-6c35-4a36-8e4e-d5fe84e683e5

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