FDA Inspection 646629 — Dixon Investments Inc
The FDA completed an inspection of Dixon Investments Inc on January 25, 2010 in Orchard Hill, GA. 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) (VAI)
- End Date
- January 25, 2010
- Fiscal Year
- 2010
- 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 |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |