# FDA 483 - Solara Active Pharma Sciences Limited - August 29, 2025

Source: https://www.keypedia.com/records/483/solara-active-pharma-sciences-limited/1238ab6a-8a14-40fd-a49d-47cdf16a045b

> FDA 483 for Solara Active Pharma Sciences Limited on August 29, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Solara Active Pharma Sciences Limited
- Inspection Date: 2025-08-29
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Solara Active Pharma Sciences Limited, an API manufacturer in New Mangalore, India, was cited for significant quality system deficiencies during an FDA inspection. The firm's Quality Unit failed to adequately investigate product complaints involving foreign particle contamination and neglected to review multiple pest alerts. Additionally, the facility lacked proper handwashing facilities with hot water and soap in manufacturing areas.

## Related Documents

- [483 - 2018-07-27](https://www.keypedia.com/records/483/solara-active-pharma-sciences-limited/da093bd6-125e-4649-a293-686bc2779480)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)

Company: https://www.keypedia.com/companies/solara-active-pharma-sciences-limited/acf65b82-5b4f-4ec5-b3c0-56f3eaed2657

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