FDA Inspection 1296652 — FillTech USA, LLC
The FDA completed an inspection of FillTech USA, LLC on December 19, 2025 in Rockwell, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 19, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rockwell, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1222 | 21 CFR 211.67(b)(4) | Cleaning SOPs/equipment identification |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |