FDA Inspection 627000 — Horiba Instruments Incorporated
The FDA completed an inspection of Horiba Instruments Incorporated on January 15, 2010 in Canton, MI. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 15, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Canton, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |
| 3250 | 21 CFR 820.72(b)(2) | Calibration documentation |
| 3397 | 21 CFR 820.80(d)(2) | Review of data and documentation |
| 3681 | 21 CFR 820.70(b) | Verification or validation of changes |
| 3701 | 21 CFR 820.250(a) | Techniques not used |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |