FDA Inspection 1118335 — Biological Specialty Company, LLC dba BioIVT, LLC
The FDA completed an inspection of Biological Specialty Company, LLC dba BioIVT, LLC on February 13, 2020 in Allentown, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 13, 2020
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Allentown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 63 | 21 CFR 606.65 | Safe, sanitary, orderly storage |