FDA Inspection 1098547 — Golden West Biosolutions LLC
The FDA completed an inspection of Golden West Biosolutions LLC on August 2, 2019 in Temecula, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 2, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Temecula, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15083 | 21 CFR 606.121(c)(4)(ii) | Expiration date for pooled Source Plasma |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |