FDA Inspection 1116865 — kdc/one Chatsworth, Inc.
The FDA completed an inspection of kdc/one Chatsworth, Inc. on February 3, 2020 in Chatsworth, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 3, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chatsworth, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |