FDA Inspection 676541 — Berkley Medical Resources, Inc
The FDA completed an inspection of Berkley Medical Resources, Inc on August 26, 2010 in Smithfield, PA. 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) (VAI)
- End Date
- August 26, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Smithfield, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |