FDA Inspection 828785 — Surgi-Care, Inc.
The FDA completed an inspection of Surgi-Care, Inc. on April 11, 2013 in Waltham, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 11, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Waltham, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |