FDA Inspection 1174076 — Kari Gran Inc.
The FDA completed an inspection of Kari Gran Inc. on July 8, 2022 in Seattle, WA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 8, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Seattle, WA (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 |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 1770 | 21 CFR 211.137(d) | Expiration date location on labeling |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4576 | 21 CFR 211.192 | No written record of investigation |