# Actimus Biosciences Private Limited – FDA 483, Jan 25, 2024

Source: https://www.keypedia.com/records/483/actimus-biosciences-private-limited/c7cdc117-827b-4d3c-9844-5706532c8e30

> FDA 483 for Actimus Biosciences Private Limited on January 25, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Actimus Biosciences Private Limited
- Inspection Date: 2024-01-25
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: ACTIMUS BIOSCIENCES LTD PVT, a biopharmaceutics clinical facility in Siripuram, Visakhapatnam, India, was cited for significant deficiencies during an FDA inspection. The observations primarily concern data integrity issues, failure to report adverse events, non-compliance with protocol-required subject confinement, unauthorized safety assessments, and inadequate record retention for echocardiogram images. These issues indicate a failure to conduct the clinical study DICH-039-22 in accordance with Good Clinical Practices, raising concerns about subject safety and data reliability.

## Related Officers

- [investigator](https://www.keypedia.com/people/courtney-n-long/32118415-bc77-4ac2-8f90-947e43cf10ff)
- [Alanna L. Mussawwir Bias](https://www.keypedia.com/people/alanna-l-mussawwir-bias/514fda77-1849-4faf-af07-e62d7c6af58e)

Company: https://www.keypedia.com/companies/actimus-biosciences-private-limited/45d945a3-0179-466c-bc20-4c3ba1d23869

Office: https://www.keypedia.com/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0