FDA Inspection 1297588 — SigmaPharm Laboratories LLC
The FDA completed an inspection of SigmaPharm Laboratories LLC on December 17, 2025 in Bensalem, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 17, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bensalem, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |