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

Source: https://www.globalkeysolutions.net/records/483/global-calcium-pvt-limited/27722625-4feb-4f4a-8623-9a07eb333e85

> 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
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Global Calcium Pvt. Limited, an Active Pharmaceutical Ingredient manufacturer in Hosur, India, revealed significant deficiencies in laboratory controls, data integrity, and quality unit responsibilities. Findings included unreliable microbiology data, failure to follow sampling procedures, inadequate Bacterial Endotoxin Test conditions, and non-reproducible cleaning processes. The firm's quality system was found ineffective in preventing data integrity breaches, and a committed retrospective assessment was not comprehensively performed.

## Related Documents

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- [483 - 2026-02-03](https://www.globalkeysolutions.net/records/483/global-calcium-pvt-limited/125a8484-376d-4547-bbb5-b9c029bfe9ba)

## Related Officers

- [Jose E. Melendez, DDC Investigator](https://www.globalkeysolutions.net/people/jose-e-melendez-ddc-investigator/bf8899c7-a800-46dc-aa24-2fa72a8cf5a3)
- [Alan A. Rivera, Investigator](https://www.globalkeysolutions.net/people/alan-a-rivera-investigator/ad0360ad-1ec4-4855-9d19-0400b686ef3f)
- [Quality System Specialist](https://www.globalkeysolutions.net/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [Alan A. Rivera](https://www.globalkeysolutions.net/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)

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

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