FDA Inspection 1066656 — JK Bioscience
The FDA completed an inspection of JK Bioscience on Sep 21, 2018 in Rancho Dominguez, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 21, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rancho Dominguez, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4410 | 21 CFR 211.194(a)(5) | Calculations performed are in the records |