FDA Inspection 1082594 — Anesthesia Associates Inc
The FDA completed an inspection of Anesthesia Associates Inc on March 14, 2019 in San Marcos, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 14, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Marcos, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |