FDA Inspection 946072 — RyMed Technologies, LLC
The FDA completed an inspection of RyMed Technologies, LLC on Sep 25, 2015 in Austin, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 25, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |