FDA Inspection 881085 — Anatomage, Inc.
The FDA completed an inspection of Anatomage, Inc. on July 7, 2014 in Santa Clara, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 7, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Santa Clara, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |