FDA Inspection 731708 — Omron Healthcare, Inc.
The FDA completed an inspection of Omron Healthcare, Inc. on May 13, 2011 in Hoffman Estates, 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). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 13, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hoffman Estates, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 4436 | 21 CFR 803.40(a) | Report of death, injury |
| 4437 | 21 CFR 803.40(b) | Report of malfunction likely to cause death or injury |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |