FDA Inspection 1276593 — Havix Group Inc
The FDA completed an inspection of Havix Group Inc on July 25, 2025 in Hoschton, 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
- July 25, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hoschton, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |