# FDA 483 - Maiva Pharma Private Limited - July 22, 2025

Source: https://www.globalkeysolutions.net/records/483/maiva-pharma-private-limited/8f9f10dd-3b8f-4fe3-aa4f-96fcdec0d154

> FDA 483 for Maiva Pharma Private Limited on July 22, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Maiva Pharma Private Limited
- Inspection Date: 2025-07-22
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Maiva Pharma Private Limited in Hosur, India, was cited with five observations during an FDA inspection from July 14-22, 2025, primarily concerning significant deficiencies in quality control, aseptic processing validation, and personnel training. Key issues include inadequate investigation of product defects, compromised data integrity in the Empower system, insufficient aseptic process simulation, unqualified visual inspection personnel, and deficient airflow studies for sterile filling lines. These findings indicate a moderate to severe level of non-compliance with cGMP regulations for sterile drug manufacturing.

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## Related Officers

- [Saleem A. Akhtar](https://www.globalkeysolutions.net/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)

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

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