FDA Inspection 1098636 — Terrain Pharmaceuticals
The FDA completed an inspection of Terrain Pharmaceuticals on August 2, 2019 in Reno, NV. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 2, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Reno, NV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4354 | 21 CFR 211.165(d) | Acceptance/Rejection Levels |