FDA Inspection 544277 — Separation Technology, Inc.
The FDA completed an inspection of Separation Technology, Inc. on Oct 28, 2008 in Sanford, FL. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 28, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sanford, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3302 | 21 CFR 820.100(a)(3) | Identifying corrective & preventive actions |
| 4189 | 21 CFR 820.198(a) | General |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |