FDA Inspection 1083505 — HTO Nevada Inc.
The FDA completed an inspection of HTO Nevada Inc. on Mar 15, 2019 in Lake Oswego, OR. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 15, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lake Oswego, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4576 | 21 CFR 211.192 | No written record of investigation |