FDA inspection
Custom Assemblies, Inc.: FDA inspection ending Jul 31, 2017
FDA inspection 1020072 · Official Action Indicated (OAI) · Pine Level, NC
Key facts
| Inspection ID | 1020072 |
|---|---|
| Firm | Custom Assemblies, Inc. |
| FEI number | 3000718854 |
| Address | 330 E. Main Street |
| City | Pine Level |
| State | NC |
| ZIP | 27568 |
| Country | United States |
| Fiscal year | 2017 |
| Inspection end date | Jul 31, 2017 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 540535 |
At a glance
- 10–99 Citations
- 1–9 Posted citations
- Yes 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