FDA inspection
SigmaPharm Laboratories LLC: FDA inspection ending Dec 17, 2025
FDA inspection 1297588 · Voluntary Action Indicated (VAI) · Bensalem, PA
Key facts
| Inspection ID | 1297588 |
|---|---|
| Firm | SigmaPharm Laboratories LLC |
| FEI number | 3005444934 |
| Address | 3375 Progress Dr |
| City | Bensalem |
| State | PA |
| ZIP | 19020 |
| Country | United States |
| Fiscal year | 2026 |
| Inspection end date | Dec 17, 2025 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
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
- 10–99 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