FDA inspection
Paragon Bioservices: FDA inspection ending Jun 19, 2020
FDA inspection 1125441 · Voluntary Action Indicated (VAI) · Harmans, MD
Key facts
| Inspection ID | 1125441 |
|---|---|
| Firm | Paragon Bioservices |
| FEI number | 3015434301 |
| Address | 7555 Harmans Rd |
| City | Harmans |
| State | MD |
| ZIP | 21077 |
| Fiscal year | 2020 |
| Inspection end date | Jun 19, 2020 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies |
| Product type | Biologics, Drugs |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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