FDA Inspection 647322 — Gulden Ophthalmics
The FDA completed an inspection of Gulden Ophthalmics on January 27, 2010 in Elkins Park, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 27, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Elkins Park, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3299 | 21 CFR 820.100(a)(1) | Procedure for analysis of data sources |
| 4189 | 21 CFR 820.198(a) | General |