FDA Inspection 581906 — Alere San Diego, Inc.
The FDA completed an inspection of Alere San Diego, Inc. on May 8, 2009 in San Diego, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 8, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3284 | 21 CFR 820.90(a) | Nonconforming product evaluation/investigation |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |