# FDA 483 - Neelakantan Anand, MD - October 24, 2019

Source: https://www.globalkeysolutions.net/records/483/neelakantan-anand-md/036e962d-c45b-4471-8790-56dbf88f964c

> FDA 483 for Neelakantan Anand, MD on October 24, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neelakantan Anand, MD
- Inspection Date: 2019-10-24
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Neelakantan Anand, MD, a clinical investigator in Los Angeles, revealed a significant issue with the reporting of serious adverse events (SAEs). The firm failed to conduct investigations in accordance with its investigational plan, specifically lacking a formal process to document the date and time of awareness for SAEs. This deficiency impacts the timely reporting of critical safety information during an ongoing investigational trial.

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Company: https://www.globalkeysolutions.net/companies/neelakantan-anand-md/d0f5adc4-b78a-4981-9f5e-70d5a0fd3972

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6