FDA Inspection 1044946 — Greenwald Surgical Company, Inc.
The FDA completed an inspection of Greenwald Surgical Company, Inc. on Mar 15, 2018 in Lake Station, IN. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 15, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lake Station, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |