FDA Inspection 1263416 — Dixon Investments Inc
The FDA completed an inspection of Dixon Investments Inc on March 11, 2025 in Orchard Hill, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 11, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Orchard Hill, GA (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 |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |