FDA Inspection 1279218 — HTO Nevada Inc.
The FDA completed an inspection of HTO Nevada Inc. on Aug 22, 2025 in Lake Oswego, OR. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 22, 2025
- Fiscal Year
- 2025
- 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 |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1498 | 21 CFR 211.122(b) | Labeling and packaging improperly approved/released |
| 1768 | 21 CFR 211.137(b) | Storage conditions |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |