# FDA 483 - Vimta Labs Limited - October 26, 2018

Source: https://www.globalkeysolutions.net/records/483/vimta-labs-limited/fa32f218-e2dd-43cb-b01d-f6f051fec941

> FDA 483 for Vimta Labs Limited on October 26, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vimta Labs Limited
- Inspection Date: 2018-10-26
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: Vimta Labs Ltd. in Hyderabad, India, a GLP Laboratory, was cited with five observations during an FDA inspection from October 22-26, 2018. The inspection revealed significant issues including inadequate environmental control equipment and monitoring, insufficient training and qualification of study personnel, and failures in documenting SOP deviations. Additionally, the quality assurance unit did not adequately inspect studies or maintain proper records, and critical raw data and documentation were not retained.

## Related Documents

- [483 - 2019-12-18](https://www.globalkeysolutions.net/records/483/vimta-labs-limited/75e60c85-7312-49b7-a243-4724806c6209)
- [483 - 2023-03-17](https://www.globalkeysolutions.net/records/483/vimta-labs-limited/263c464e-744f-4b50-a0ab-f6e95142ada2)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/jennifer-c-adams/85608566-bd13-41d8-b86e-cc9111c7dfe5)

Company: https://www.globalkeysolutions.net/companies/vimta-labs-limited/74303e4b-f6dc-4ce6-8216-62d716ea8046

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4