FDA Inspection 972651 — Mid-Atlantic Surgical Systems, LLC
The FDA completed an inspection of Mid-Atlantic Surgical Systems, LLC on Mar 30, 2016 in Carnegie, PA. 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). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 30, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Carnegie, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12311 | 21 CFR 1271.160(b)(1) | Ensuring appropriate core requirements followed |
| 12324 | 21 CFR 1271.160(b)(6) | Deviations--Investigation, documenting, trending |
| 12326 | 21 CFR 1271.160(c) | Quality audits performed periodically |
| 12340 | 21 CFR 1271.180(d) | Adopted from another organization |
| 12365 | 21 CFR 1271.195(d) | Documentation not maintained |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |