FDA Inspection 844374 — SigmaPharm Laboratories LLC
The FDA completed an inspection of SigmaPharm Laboratories LLC on August 13, 2013 in Bensalem, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 13, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Bensalem, PA (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6728 | 21 CFR 314.80(b) | Failure to review ADE information |
| 6833 | 21 CFR 314.80(c)(2)(ii)(A) | Incomplete periodic safety report |