# FDA 483 - Maiva Pharma Private Limited - August 02, 2019

Source: https://www.keypedia.com/records/483/maiva-pharma-private-limited/187fc83e-ebb7-4d3c-9621-9fdb34c353e4

> FDA 483 for Maiva Pharma Private Limited on August 02, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Maiva Pharma Private Limited
- Inspection Date: 2019-08-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Global Pharmatech Private Limited in Hosur, India, was inspected by the FDA from July 24 to August 2, 2019, resulting in two observations. The firm failed to thoroughly investigate the root cause of particulate matter found in a distributed injection batch. Additionally, procedures to prevent microbiological contamination were not adequately established, specifically regarding the validation and tracking of sterilization cycles for sterile goggles used in aseptic areas.

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## Related Officers

- [Samina S. Khan](https://www.keypedia.com/people/samina-s-khan/ca3e266c-aa69-4c28-9901-d344e0c259fd)

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