FDA inspection
Bi-Coastal Pharma International: FDA inspection ending Jan 14, 2022
FDA inspection 1161078 · Official Action Indicated (OAI) · Shrewsbury, NJ
Key facts
| Inspection ID | 1161078 |
|---|---|
| Firm | Bi-Coastal Pharma International |
| FEI number | 3013263547 |
| Address | 1161 Broad St Ste 216 |
| City | Shrewsbury |
| State | NJ |
| ZIP | 07702 |
| Country | United States |
| Fiscal year | 2022 |
| Inspection end date | Jan 14, 2022 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 628196 |
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