FDA Inspection 1012254 — Hemcare of Oregon, Inc.
The FDA completed an inspection of Hemcare of Oregon, Inc. on April 26, 2017 in Wilsonville, OR. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 26, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Wilsonville, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |