# FDA 483 - Vimta Labs Limited - March 17, 2023

Source: https://www.globalkeysolutions.net/records/483/vimta-labs-limited/263c464e-744f-4b50-a0ab-f6e95142ada2

> FDA 483 for Vimta Labs Limited on March 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vimta Labs Limited
- Inspection Date: 2023-03-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Vimta Labs Limited's control testing laboratory in Hyderabad, India, revealed significant deficiencies in equipment cleaning, maintenance, and environmental controls. Observations included visible corrosion and residue in sterility testing areas, growth in incubators, and a broken differential pressure gauge. Additionally, the firm lacked sufficiently detailed written procedures for equipment cleaning and maintenance.

## Related Documents

- [483 - 2018-10-26](https://www.globalkeysolutions.net/records/483/vimta-labs-limited/fa32f218-e2dd-43cb-b01d-f6f051fec941)
- [483 - 2019-12-18](https://www.globalkeysolutions.net/records/483/vimta-labs-limited/75e60c85-7312-49b7-a243-4724806c6209)

## Related Officers

- [Rose L. Jean-Mary](https://www.globalkeysolutions.net/people/rose-l-jean-mary/398483f5-12f7-429b-8a13-c068b41ff3ed)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1