FDA Inspection 835336 — Olympus Corporation Of The Americas
The FDA completed an inspection of Olympus Corporation Of The Americas on May 31, 2013 in Center Valley, PA. 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
- May 31, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Center Valley, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 733 | 21 CFR 803.50(b)(1) | Reporting Information Reasonably Known |