FDA Inspection 1021970 — Greiner Bio-One North America, Inc.
The FDA completed an inspection of Greiner Bio-One North America, Inc. on Aug 17, 2017 in Monroe, NC. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 17, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Monroe, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |