FDA Inspection 1325530 — GUIDEMIA TECHNOLOGIES LLC
The FDA completed an inspection of GUIDEMIA TECHNOLOGIES LLC on Jul 6, 2026 in Buena Park, CA. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 6, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Buena Park, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22801 | 21 CFR 830.310(b) | GUDID Information required for unique device identification. |
| 23072 | ISO 13485:2016 Clause 6.2(b) | Personnel training not provided |
| 23219 | ISO 13485:2016 Clause 8.2.2 | Complaint handling records not maintained |
| 23259 | ISO 13485:2016 Clause 8.5.2 | Corrective action records not maintained |