# FDA 483 - Lotus Labs Pvt. Ltd. - Unknown Date

Source: https://www.keypedia.com/records/483/lotus-labs-pvt-ltd/13462729-5024-4abf-a76e-fd1372729d2c

> FDA 483 for Lotus Labs Pvt. Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lotus Labs Pvt. Ltd.
- Product Type: drugs
- Office Name: FDA District Office — New Delhi, Delhi
- Summary: Lotus Labs Private Limited in Bangalore, India, a Contract Research Organization (CRO), was cited for three significant issues during an FDA inspection. These included performing screening procedures without proper informed consent, failing to adequately follow up on an adverse event until its resolution, and enrolling subjects who met exclusion criteria for clinical studies. The findings indicate deficiencies in clinical trial conduct and subject protection.

## Related Documents

- [483 - 2017-08-22](https://www.keypedia.com/records/483/lotus-labs-pvt-ltd/f094a6d2-ab59-4fb0-9281-a5f99899e297)

## Related Officers

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Company: https://www.keypedia.com/companies/lotus-labs-pvt-ltd/e5c0d967-2a8c-4e7c-9d56-b3c7f3211880

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