FDA Inspection 780710 — R.K. Manufacturing Corp Of Connecticut
The FDA completed an inspection of R.K. Manufacturing Corp Of Connecticut on May 4, 2012 in Danbury, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 4, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Danbury, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3696 | 21 CFR 820.100(b) | Documentation |