FDA Inspection 1287352 — Embecta Medical 1, LLC.
The FDA completed an inspection of Embecta Medical 1, LLC. on Oct 17, 2025 in Holdrege, NE. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 17, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Holdrege, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |