# FDA 483 - Vimta Labs, Limited - August 16, 2019

Source: https://www.globalkeysolutions.net/records/483/vimta-labs-limited/7e6fae6b-de6a-4948-91f9-28e1d949ff0e

> FDA 483 for Vimta Labs, Limited on August 16, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vimta Labs, Limited
- Inspection Date: 2019-08-16
- Product Type: drugs
- Office Name: FDA District Office — Silver Springs, Maryland
- Summary: An FDA inspection of Vimta Labs Ltd. in Hyderabad, India, revealed a significant failure to maintain adequate case histories for subjects enrolled in two bioequivalence studies. The firm did not ensure that all subjects had readable chest X-rays, a critical requirement specified in their ethics committee-approved protocols. This indicates a serious deficiency in data integrity and adherence to study protocols.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/craig-a-garmendia/6a17e361-7085-4d55-92b2-37fcaf2f55de)

Company: https://www.globalkeysolutions.net/companies/vimta-labs-limited/5982ebf6-7933-402e-b729-fb30720495c0

Office: https://www.globalkeysolutions.net/offices/fda-district-office-silver-springs-maryland/079bb75c-3759-4baa-baed-4159edd64552