FDA Inspection 1057766 — Sarstedt Inc
The FDA completed an inspection of Sarstedt Inc on Jul 2, 2018 in Newton, NC. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jul 2, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Newton, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |