FDA Inspection 579181 — Johnson Labs Inc
The FDA completed an inspection of Johnson Labs Inc on April 23, 2009 in Troy, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 23, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Troy, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |