FDA Inspection 768698 — Linemaster Switch Corporation
The FDA completed an inspection of Linemaster Switch Corporation on Jan 12, 2012 in Woodstock, CT. 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
- Jan 12, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Woodstock, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |