# FDA 483 - AB Science - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/ab-science/7439e211-4fa4-4d04-81d9-ce1115a55438

> FDA 483 for AB Science on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AB Science
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: AB Science, a sponsor located in Paris, France, was inspected by the FDA from September 22-26, 2014, and received a Form 483 with three observations. The inspection revealed significant deficiencies in the monitoring of clinical investigations, including inadequate safety reporting, untimely data submission, and missing monitoring visit reports. Additionally, the firm failed to provide proper training to clinical investigators and did not ensure timely reporting of serious adverse events as required by study protocols.

## Related Officers

- [Michelle Safarik, MSPAS, PA-C, RAC](https://www.globalkeysolutions.net/people/michelle-safarik-mspas-pa-c-rac/e5705b03-ea50-4ec5-8367-b7e578517097)
- [issuing_officer](https://www.globalkeysolutions.net/people/ni-a-khin/31efd30a-c5ed-46ec-9522-19c8bd8ce12d)
- [investigator](https://www.globalkeysolutions.net/people/barbara-d-wright/c824bcb9-76fb-4e83-86d0-013a9584c137)

Company: https://www.globalkeysolutions.net/companies/ab-science/3f308e3c-9b42-4f96-a47a-1ad9b8ead53a

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321