FDA Inspection 638764 — Surgi-Care, Inc.
The FDA completed an inspection of Surgi-Care, Inc. on January 14, 2009 in Waltham, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 14, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Waltham, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12311 | 21 CFR 1271.160(b)(1) | Ensuring appropriate core requirements followed |
| 12322 | 21 CFR 1271.160(b)(4) | Training of personnel |
| 12323 | 21 CFR 1271.160(b)(5) | Monitoring systems |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |
| 12436 | 21 CFR 1271.270(a) | Accurate, indelible, legible |