FDA Inspection 814211 — Hemcare of Oregon, Inc.
The FDA completed an inspection of Hemcare of Oregon, Inc. on January 7, 2013 in Wilsonville, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 7, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Wilsonville, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |