FDA Inspection
Rare Antibody Antigen Supply, Inc.Rare Antibody Antigen Supply, Inc. – FDA Inspection, Mar 23, 2021
Record Details
This FDA Inspection record concerns Rare Antibody Antigen Supply, Inc., with an inspection on March 23, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 23, 2021
- Product Type
- Drugs
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ID · 7b45608f-4f9d-4037-814a-b0e254cc1158
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1136980
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 312.59Unused drug disposition (sponsor)
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 312.20(a)Failure to submit an IND
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