FDA Inspection 1200721 — kdc/one Chatsworth, Inc.
The FDA completed an inspection of kdc/one Chatsworth, Inc. on March 24, 2023 in Chatsworth, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 24, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chatsworth, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |