FDA Inspection 615080 — Inotech Biosystems Intl., Inc
The FDA completed an inspection of Inotech Biosystems Intl., Inc on Sep 17, 2009 in Derwood, MD. 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
- Sep 17, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Derwood, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3291 | 21 CFR 820.100(b) | Procedures |
| 4189 | 21 CFR 820.198(a) | General |
| 4430 | 21 CFR 803.18(d)(1) | Distributor responsibilities for complaint records |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |