# FDA 483 - Maiva Pharma Private Limited - October 29, 2022

Source: https://www.keypedia.com/records/483/maiva-pharma-private-limited/d92be8a0-4356-4d0e-b6ee-a42c44642842

> FDA 483 for Maiva Pharma Private Limited on October 29, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Maiva Pharma Private Limited
- Inspection Date: 2022-10-29
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Maiva Pharma Private Limited, a sterile drug manufacturer in Hosur, India, revealed significant deficiencies across its operations. The firm was cited for severe issues with data integrity and computer system controls, inadequate environmental monitoring in aseptic processing areas, and insufficient validation of cleaning, disinfection, and aseptic processes. Additionally, the firm failed to properly document personnel performing critical manufacturing steps and exhibited poor airflow control and visualization studies.

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## Related Officers

- [Thomas J. Arista](https://www.keypedia.com/people/thomas-j-arista/37905892-3285-4f3f-b4b5-f963df1e59d3)
- [Dipesh K. Shah](https://www.keypedia.com/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.keypedia.com/companies/maiva-pharma-private-limited/3231d685-f5ad-401e-b1ae-66c6a6d8e8b7

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