FDA Inspection 890166 — METRO OPTICS, INC
The FDA completed an inspection of METRO OPTICS, INC on Aug 7, 2014 in Dallas, TX. 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
- Aug 7, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |