# FDA 483 - ARCA biopharma, Inc. - March 09, 2009

Source: https://www.keypedia.com/records/483/arca-biopharma-inc/f4a272a7-bd8f-4003-924c-d6c6568e3be1

> FDA 483 for ARCA biopharma, Inc. on March 09, 2009. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ARCA biopharma, Inc.
- Inspection Date: 2009-03-09
- Product Type: drugs
- Office Name: Denver District Office
- Summary: ARCA biopharma, Inc. in Broomfield, CO, was inspected as a Sponsor-Monitor and received a Form 483 with two observations. The inspection revealed significant issues with recordkeeping, specifically regarding investigational drug disposition and the retention of essential study documentation. These findings indicate a moderate level of non-compliance with regulatory requirements for clinical trial oversight and record management.

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Company: https://www.keypedia.com/companies/arca-biopharma-inc/ef5a6e68-a071-454d-92f9-0aa72ded1739

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face