FDA Inspection 841998 — HTO Nevada Inc. dba Kirkman
The FDA completed an inspection of HTO Nevada Inc. dba Kirkman on August 6, 2013 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). 15 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 6, 2013
- Fiscal Year
- 2013
- 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 |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |