# FDA EIR - Lifepoint Research, LLP - January 14, 2022

Source: https://www.keypedia.com/records/eir/lifepoint-research-llp/2d1f62a3-8193-4d3d-91d4-3790fbd7c43e

> FDA EIR for Lifepoint Research, LLP on January 14, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Lifepoint Research, LLP
- Inspection Date: 2022-01-14
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection was conducted at Lifepoint Research, LLP in Wakad, Pune, India, from January 10 to January 14, 2022. The inspection was a high-priority bioequivalence assessment of a clinical study for Vigabatrin tablets (ANDA 210042). This review was conducted under the regulatory framework of 21 CFR Part 320 and Compliance Program 7348.003, focusing on Clinical In-Vivo BA/BE studies. The inspection revealed significant concerns, resulting in the issuance of an FDA Form 483 for failure to conduct foreign clinical studies in accordance with good clinical practices. A main violation was the site's inability to perform required vision assessments, including visual field interpretation, because the contracted ophthalmologist lacked the necessary perimetry device on-site, leading to unscheduled subject visits and unavailability of the device for verification. Another issue involved a pre-screened subject who was not randomized but inappropriately signed a Post-trial Access Informed Consent Form and received investigational medication. Management, specifically Dr. Sunil Chaudhary, Director of the Clinical Research Department, committed to correcting these issues and submitting a written response to the FDA within fifteen business days.

## Related Officers

- [Janete F. Guardia](https://www.keypedia.com/people/janete-f-guardia/2405f83f-7ea9-4056-afbd-7d9c00a6e169)

Company: https://www.keypedia.com/companies/lifepoint-research-llp/f0b77bce-b784-41ca-911a-4b0c8d0993af

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8