FDA Inspection 818944 — Stellartech Research Corporation
The FDA completed an inspection of Stellartech Research Corporation on Feb 19, 2013 in Milpitas, CA. 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
- Feb 19, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Milpitas, CA (United States)
Additional details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3696 | 21 CFR 820.100(b) | Documentation |