FDA Inspection 638728 — Health-Mor, Inc
The FDA completed an inspection of Health-Mor, Inc on January 15, 2010 in Cleveland, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 15, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cleveland, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 537 | 21 CFR 820.70(a) | Production processes |