# FDA 483 - Solara Active Pharma Sciences Limited - July 27, 2018

Source: https://www.keypedia.com/records/483/solara-active-pharma-sciences-limited/da093bd6-125e-4649-a293-686bc2779480

> FDA 483 for Solara Active Pharma Sciences Limited on July 27, 2018. 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: 2018-07-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Solara Active Pharma Sciences Limited in New Mangalore, Karnataka, India, revealed significant deficiencies in their manufacturing and laboratory controls. Observations included inadequate written procedures for equipment cleaning and a lack of validation for cleaning processes. Additionally, the firm's method validation for forced degradation studies of active pharmaceutical ingredients was found to be insufficient.

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## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.keypedia.com/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)

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