FDA Inspection 629685 — Biosearch Medical Products, Inc.
The FDA completed an inspection of Biosearch Medical Products, Inc. on Nov 19, 2009 in Concord, NC. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 19, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Concord, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |