FDA Inspection 1201377 — Japan Food Research Laboratories
The FDA completed an inspection of Japan Food Research Laboratories on March 29, 2023 in Ibaraki. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 29, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ibaraki (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3604 | 21 CFR 211.160(b)(1) | Determination of conformance |