FDA Inspection 933396 — HTO Nevada Inc. dba Kirkman
The FDA completed an inspection of HTO Nevada Inc. dba Kirkman on June 24, 2015 in Lake Oswego, OR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 24, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Lake Oswego, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |