FDA Inspection 651460 — Microline Surgical, Inc.
The FDA completed an inspection of Microline Surgical, Inc. on February 25, 2010 in Beverly, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 25, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Beverly, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3291 | 21 CFR 820.100(b) | Procedures |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 4189 | 21 CFR 820.198(a) | General |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |