FDA Inspection 1258821 — HORIZON TOOL INC
The FDA completed an inspection of HORIZON TOOL INC on January 16, 2025 in Greensboro, NC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 16, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Greensboro, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1722 | 21 CFR 211.134(a) | Correct labels during finishing operations |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 4576 | 21 CFR 211.192 | No written record of investigation |