FDA Inspection 754698 — Apex Medical Technologies, Inc.
The FDA completed an inspection of Apex Medical Technologies, Inc. on November 30, 2011 in San Diego, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 30, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3111 | 21 CFR 820.70(f) | Buildings |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |