FDA Inspection 1136980 — Rare Antibody Antigen Supply, Inc.
The FDA completed an inspection of Rare Antibody Antigen Supply, Inc. on Mar 23, 2021 in Thousand Oaks, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 23, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Thousand Oaks, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7487 | 21 CFR 312.59 | Unused drug disposition (sponsor) |
| 7638 | 21 CFR 312.20(a) | Failure to submit an IND |