FDA Inspection 1031918 — Exact Medical Manufacturing, Inc.
The FDA completed an inspection of Exact Medical Manufacturing, Inc. on Nov 21, 2017 in Lancaster, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Nov 21, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lancaster, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |