FDA Inspection
ARCA biopharma, Inc.ARCA biopharma, Inc. – FDA Inspection, Mar 9, 2009
Record Details
This FDA Inspection record concerns ARCA biopharma, Inc., with an inspection on March 9, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- ARCA biopharma, Inc.
- Inspection Date
- March 9, 2009
- Product Type
- Drugs
View Company Profile
ID · e6dec55c-a89b-4715-b526-39905bcb1ed7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 601115
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 312.59Records of unused drug disposition
- 21 CFR 312.57(c)Record retention requirement
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