FDA Inspection 941193 — Direct Rx
The FDA completed an inspection of Direct Rx on August 13, 2015 in Dawsonville, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 13, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dawsonville, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |