FDA Inspection 591198 — Bisco, Inc.
The FDA completed an inspection of Bisco, Inc. on Jun 22, 2009 in Schaumburg, 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 22, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Schaumburg, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2351 | 21 CFR 820.25(b) | Training |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3304 | 21 CFR 820.100(a)(5) | Changes to correct/prevent quality problems |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 733 | 21 CFR 803.50(b)(1) | Reporting Information Reasonably Known |