FDA Inspection 654826 — Sechrist Industries Inc
The FDA completed an inspection of Sechrist Industries Inc on Mar 26, 2010 in Anaheim, 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). 14 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 26, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Anaheim, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2628 | 21 CFR 820.30(e) | Design review procedures - personnel |
| 3284 | 21 CFR 820.90(a) | Nonconforming product evaluation/investigation |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3379 | 21 CFR 820.198(e)(5) | Nature and details of complaint |
| 3382 | 21 CFR 820.198(e)(8) | Reply to complainant |
| 3681 | 21 CFR 820.70(b) | Verification or validation of changes |
| 3689 | 21 CFR 820.100(a)(2) | Investigation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 4189 | 21 CFR 820.198(a) | General |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |