# FDA 483 - Global Calcium Pvt. Limited - Unknown Date

Source: https://www.keypedia.com/records/483/global-calcium-pvt-limited/da99a8aa-c736-4dab-b01f-ca74275265bd

> FDA 483 for Global Calcium Pvt. Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Global Calcium Pvt. Limited
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Global Calcium Pvt. Limited in Hosur, India, an API manufacturer, revealed severe data integrity issues and multiple GMP violations. The firm was found to be fabricating batch records and other production documentation for US market products, and subsequently deleting related electronic files. Additionally, the company failed to maintain adequate stability testing programs, establish proper impurity profiles, and ensure facility and equipment maintenance to prevent contamination, indicating a systemic breakdown in quality control.

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## Related Officers

- [Teresa I. Navas](https://www.keypedia.com/people/teresa-i-navas/43f747c0-18c2-4630-bab9-936204aa93aa)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.keypedia.com/companies/global-calcium-pvt-limited/274540f7-e7a4-47fb-b3a0-61fb5e85d807

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