FDA Inspection 649662 — Lcr-Hallcrest, Llc.
The FDA completed an inspection of Lcr-Hallcrest, Llc. on Feb 26, 2010 in Glenview, 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 26, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Glenview, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3284 | 21 CFR 820.90(a) | Nonconforming product evaluation/investigation |
| 3380 | 21 CFR 820.198(e)(6) | Results of investigation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |