FDA Inspection 988293 — Meta Labs Pharmaceuticals, LLC
The FDA completed an inspection of Meta Labs Pharmaceuticals, LLC on Sep 16, 2016 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). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 16, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Roswell, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 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 |
| 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 |