FDA Inspection 1020101 — OphthalMed LLC
The FDA completed an inspection of OphthalMed LLC on May 1, 2017 in Roswell, GA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 1, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Roswell, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3200 | 21 CFR 820.40(a) | Document locations, Dissemination, etc. |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 3837 | 21 CFR 820.25(b) | Training records |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |