FDA Inspection 700747 — RD Medical Manufacturing, Inc.
The FDA completed an inspection of RD Medical Manufacturing, Inc. on November 18, 2010 in Las Piedras, PR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 18, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Las Piedras, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |