# FDA 483 - Maiva Pharma Private Limited - February 10, 2026

Source: https://www.keypedia.com/records/483/maiva-pharma-private-limited/ac94aaac-22ab-4189-bb2e-bd97d2396c01

> FDA 483 for Maiva Pharma Private Limited on February 10, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Maiva Pharma Private Limited
- Inspection Date: 2026-02-10
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Maiva Pharma Private Limited, a sterile drug manufacturer, from February 10-20, 2026, revealed significant deviations from Good Manufacturing Practices. Key observations in the FDA Form 483 document include critical data integrity failures, with numerous original manufacturing and control records found discarded and not properly reconciled. The inspection identified substantial deficiencies in aseptic processing and environmental control, such as media fill simulations that do not reflect routine operations, inadequate investigations into microbial excursions, and insufficient environmental monitoring during critical interventions and pre-assembly activities. Furthermore, the firm failed to thoroughly investigate various discrepancies, including out-of-specification results and customer complaints, often lacking supporting documentation or scientific justification for root cause determinations. Laboratory controls were compromised by improper testing techniques, and the Quality Unit exhibited a lack of independent oversight in document destruction and inadequate visual inspection qualification. These findings highlight a need for comprehensive corrective and preventive actions to ensure product quality, safety, and regulatory compliance.

## Related Documents

- [483 - 2019-08-02](https://www.keypedia.com/records/483/maiva-pharma-private-limited/187fc83e-ebb7-4d3c-9621-9fdb34c353e4)
- [483 - 2022-10-29](https://www.keypedia.com/records/483/maiva-pharma-private-limited/d92be8a0-4356-4d0e-b6ee-a42c44642842)
- [483 - 2025-07-22](https://www.keypedia.com/records/483/maiva-pharma-private-limited/8f9f10dd-3b8f-4fe3-aa4f-96fcdec0d154)
- [483 - 2026-02-20](https://www.keypedia.com/records/483/maiva-pharma-private-limited/417ce324-b6b1-4f50-a654-ef3265e6215d)

## 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/maiva-pharma-private-limited/3231d685-f5ad-401e-b1ae-66c6a6d8e8b7

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