FDA Inspection 1311782 — All Quality & Services, Inc.
The FDA completed an inspection of All Quality & Services, Inc. on April 10, 2026 in Fremont, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 10, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fremont, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23063 | ISO 13485:2016 Clause 5.6.1 | Management review records not maintained |
| 23070 | ISO 13485:2016 Clause 6.2 | Process(es) for personnel competence, training and awareness not documented |
| 23237 | ISO 13485:2016 Clause 8.3.1 | Procedure for nonconforming product not documented |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |