# FDA 483 - Vimta Labs Limited - December 18, 2019

Source: https://www.keypedia.com/records/483/vimta-labs-limited/75e60c85-7312-49b7-a243-4724806c6209

> FDA 483 for Vimta Labs Limited on December 18, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vimta Labs Limited
- Inspection Date: 2019-12-18
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Vimta Labs Ltd. in Hyderabad, India, a GLP Laboratory, was inspected by the FDA and received 11 observations. The inspection revealed significant deficiencies in personnel training, protocol adherence, facility design, test article control, SOP establishment, data integrity, and final report completeness. These issues indicate a systemic failure to maintain adequate Good Laboratory Practice standards.

## Related Documents

- [483 - 2018-10-26](https://www.keypedia.com/records/483/vimta-labs-limited/fa32f218-e2dd-43cb-b01d-f6f051fec941)
- [483 - 2023-03-17](https://www.keypedia.com/records/483/vimta-labs-limited/263c464e-744f-4b50-a0ab-f6e95142ada2)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/zhou-chen/03362438-eba1-4010-b6b1-5cccf25a824c)
- [Janete F. Guardia](https://www.keypedia.com/people/janete-f-guardia/2405f83f-7ea9-4056-afbd-7d9c00a6e169)
- [issuing_officer](https://www.keypedia.com/people/mark-j-seaton/640c2deb-25ff-4e2e-8f48-d15d31f9c5bf)

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

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