FDA Inspection 1083505 — HTO Nevada Inc. dba Kirkman
The FDA completed an inspection of HTO Nevada Inc. dba Kirkman on March 15, 2019 in Lake Oswego, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 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 |