FDA Inspection 1132829 — Life Science Outsourcing, Inc.
The FDA completed an inspection of Life Science Outsourcing, Inc. on November 12, 2020 in Brea, CA. 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
- November 12, 2020
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brea, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |