FDA Inspection 768395 — FHC, Inc.
The FDA completed an inspection of FHC, Inc. on Feb 10, 2012 in Bowdoin, ME. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 10, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Bowdoin, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3138 | 21 CFR 820.130 | Packaging |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 537 | 21 CFR 820.70(a) | Production processes |