FDA Inspection 1279218 — HTO Nevada Inc. dba Kirkman
The FDA completed an inspection of HTO Nevada Inc. dba Kirkman on August 22, 2025 in Lake Oswego, OR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 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 |