FDA Inspection 1009414 — Laser Pharmaceuticals LLC
The FDA completed an inspection of Laser Pharmaceuticals LLC on Dec 16, 2016 in Greenville, SC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 16, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Greenville, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |