FDA Inspection 936811 — Optical Integrity, Inc.
The FDA completed an inspection of Optical Integrity, Inc. on Jul 30, 2015 in Panama City Beach, FL. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 30, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Panama City Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |