FDA Inspection 1250935 — Department Of Defense - Navy
The FDA completed an inspection of Department Of Defense - Navy on Oct 3, 2024 in Bethesda, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 3, 2024
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Bethesda, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15038 | 21 CFR 610.47(a)(3) | Notify Consignees [Collecting Establishment] |
| 15069 | 21 CFR 610.46(a)(3) | Notify Consignees [Collecting Establishment] |
| 18092 | 21 CFR 630.10(f)(6)(ii) | Physical Assessment Determination - Skin Examination |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |