FDA Inspection 700011 — Rauland-Borg Corp
The FDA completed an inspection of Rauland-Borg Corp on Nov 29, 2010 in Mount Prospect, IL. 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
- Nov 29, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mount Prospect, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |