FDA Inspection 907142 — Repro Parts, Inc.
The FDA completed an inspection of Repro Parts, Inc. on Dec 18, 2014 in Elmhurst, 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 18, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Elmhurst, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |