FDA inspection
CEP Bio-Coat, LLC: FDA inspection ending Feb 15, 2019
FDA inspection 1079579 · Official Action Indicated (OAI) · Farmington Hills, MI
Key facts
| Inspection ID | 1079579 |
|---|---|
| Firm | CEP Bio-Coat, LLC |
| FEI number | 3011277306 |
| Address | 23149 Commerce Dr |
| City | Farmington Hills |
| State | MI |
| ZIP | 48335 |
| Country | United States |
| Fiscal year | 2019 |
| Inspection end date | Feb 15, 2019 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 580112 |
At a glance
- 1–9 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