1111063
Escalon Medical Corp. — FEI 2183477
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 25, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- New Berlin, WI (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3109 | 21 CFR 820.70(d) | Personnel requirements, Lack of or inadequate requirements |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 3837 | 21 CFR 820.25(b) | Training records |
| 537 | 21 CFR 820.70(a) | Production processes |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |