FDA Inspection 601115 — ARCA Biopharma, Inc.
The FDA completed an inspection of ARCA Biopharma, Inc. on Mar 9, 2009 in Westminster, CO. 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 9, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Westminster, CO (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 7488 | 21 CFR 312.59 | Records of unused drug disposition |
| 7558 | 21 CFR 312.57(c) | Record retention requirement |