# FDA 483 - Global Calcium Pvt. Limited - February 03, 2026

Source: https://www.keypedia.com/records/483/global-calcium-pvt-limited/125a8484-376d-4547-bbb5-b9c029bfe9ba

> FDA 483 for Global Calcium Pvt. Limited on February 03, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Global Calcium Pvt. Limited
- Inspection Date: 2026-02-03
- Product Type: drugs
- Summary: Between January 27 and February 3, 2026, the FDA inspected Global Calcium Pvt. Limited, an active pharmaceutical ingredient manufacturer in Hosur, India. The inspection resulted in a Form 483 detailing six major areas of concern regarding the facility"s compliance with manufacturing standards. A primary issue involved significant data integrity failures in the microbiology laboratory, where staff recorded inaccurate microbial counts and lacked the training necessary to properly identify contaminated samples. Investigators also identified discrepancies between manual logs and biometric access records, indicating that required water samples were not actually collected at the times reported. Further violations included the use of unvalidated cleaning procedures that relied on undocumented, random volumes of cleaning agents, and laboratory equipment issues that compromised endotoxin testing. The firm’s Quality Unit was found to have failed in its oversight responsibilities, specifically by neglecting to perform a comprehensive retrospective review of past batches as previously committed. Additionally, the company"s internal reporting system for quality concerns was deemed inadequate because the reporting box was placed under a security camera, potentially discouraging employees from reporting issues. This document serves as a preliminary report of objectionable conditions. Global Calcium Pvt. Limited is required to respond to these observations by detailing their planned or implemented corrective actions. Failure to address these systemic documentation and quality control failures could lead to further regulatory enforcement, as the current findings suggest a lack of reliable data to ensure the safety and purity of the drug substances produced.

## Related Documents

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- [483 - 2026-02-03](https://www.keypedia.com/records/483/global-calcium-pvt-limited/27722625-4feb-4f4a-8623-9a07eb333e85)

## Related Officers

- [Alan A. Rivera](https://www.keypedia.com/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)
- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)

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