Drug factory · FDA FEI 3012841169
Havix Group Inc d/b/a Aavis Pharmaceuticals
9488 Jackson Trail Road, Hoschton, GA, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 25, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2019: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 25, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jan 30, 2019 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jul 25, 2025 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - Protective Apparel Not Worn 21 CFR 211.28(a)
Protective apparel is not worn as necessary to protect drug products from contamination. - Cleaning SOPs/instructions 21 CFR 211.67(b)(3)
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
Registered with FDA for: analysis; label; manufacture; pack; relabel; repack.