FDA Inspection 1040164 — All Quality & Services, Inc.
The FDA completed an inspection of All Quality & Services, Inc. on Feb 1, 2018 in Fremont, 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 1, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fremont, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3239 | 21 CFR 820.72(b) | Remedial action - documentation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |