FDA Inspection 1097808 — FHC, Inc.
The FDA completed an inspection of FHC, Inc. on Jul 24, 2019 in Bowdoin, ME. 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
- Jul 24, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Bowdoin, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14719 | 21 CFR 820.30(h) | Incorrect translation to production specifications |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |