FDA Inspection 862743 — Meta Labs Pharmaceuticals, LLC
The FDA completed an inspection of Meta Labs Pharmaceuticals, LLC on Jan 21, 2014 in Roswell, GA. 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). 14 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 21, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Roswell, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |