FDA Inspection 1330954 — Vitalcor, Inc.
The FDA completed an inspection of Vitalcor, Inc. on Aug 14, 2026 in Westmont, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 14, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Westmont, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 23024 | ISO 13485:2016 Clause 4.1.5 | Inadequate monitoring and control over outsourced processes |
| 23038 | ISO 13485:2016 Clause 4.2.4 | Lack of document control |
| 23060 | ISO 13485:2016 Clause 5.6.1 | Management review procedures not documented |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |