FDA Inspection 557524 — Tecomet, Inc.
The FDA completed an inspection of Tecomet, Inc. on Dec 23, 2008 in Woburn, MA. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 23, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Woburn, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3687 | 21 CFR 820.100(a)(1) | Analysis of data sources |
| 537 | 21 CFR 820.70(a) | Production processes |