FDA Inspection 797536 — Medgyn Products, Inc.
The FDA completed an inspection of Medgyn Products, Inc. on Sep 6, 2012 in Westmont, IL. 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). 12 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 6, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Westmont, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2338 | 21 CFR 820.22 | Quality audit - audit report review |
| 2339 | 21 CFR 820.22 | Quality Audit/Reaudit - documentation |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3159 | 21 CFR 820.184 | DHR content |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3346 | 21 CFR 820.200(b) | Analyzing service report |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |