FDA Inspection 1320898 — Medcura, Inc.
The FDA completed an inspection of Medcura, Inc. on Jun 23, 2026 in Riverdale, MD. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 23, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Riverdale, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23158 | ISO 13485:2016 Clause 7.5.2 | Requirements for cleanliness or contamination control of product not documented |
| 23193 | ISO 13485:2016 Clause 7.6 | Procedures for monitoring and measuring equipment requirements not documented |
| 23249 | ISO 13485:2016 Clause 8.4 | Procedures for analysis of data not documented |