FDA inspection
EXACT MEDICAL MANUFACTURING, INC.: FDA inspection ending May 2, 2019
FDA inspection 1089637 · Official Action Indicated (OAI) · Changzhou
Key facts
| Inspection ID | 1089637 |
|---|---|
| Firm | EXACT MEDICAL MANUFACTURING, INC. |
| FEI number | 3013443304 |
| Address | D Changzhou, # 21 Qingjiang Road |
| City | Changzhou |
| Country | China |
| Fiscal year | 2019 |
| Inspection end date | May 2, 2019 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data