FDA Inspection 650786 — Etymotic Research, Inc.
The FDA completed an inspection of Etymotic Research, Inc. on Mar 2, 2010 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). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 2, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Schaumburg, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3161 | 21 CFR 820.184(a) | DHR content - manufacturing dates |
| 3299 | 21 CFR 820.100(a)(1) | Procedure for analysis of data sources |
| 3300 | 21 CFR 820.100(a)(1) | Statistical methodology |
| 3304 | 21 CFR 820.100(a)(5) | Changes to correct/prevent quality problems |
| 3332 | 21 CFR 820.184(e) | ID label, labeling |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 3691 | 21 CFR 820.100(a)(4) | Verification vs validation |
| 4058 | 21 CFR 820.20 | Management responsibility |