FDA Inspection 577506 — Horiba Instruments Incorporated
The FDA completed an inspection of Horiba Instruments Incorporated on April 8, 2009 in Canton, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 8, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Canton, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2330 | 21 CFR 820.22 | Quality audit corrective action, reaudits {see also 820.100} |
| 2470 | 21 CFR 820.30(c) | Design input procedures - appropriateness |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 4192 | 21 CFR 806.10(a)(2) | Report of violation of the Act (see 803.52(e)(9)) |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |