# FDA 483 - Abhilasha Pharma Private Ltd - February 03, 2025

Source: https://www.keypedia.com/records/483/abhilasha-pharma-private-ltd/f5c923a5-9e07-4d93-8865-1eda5b5cacf6

> FDA 483 for Abhilasha Pharma Private Ltd on February 03, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abhilasha Pharma Private Ltd
- Inspection Date: 2025-02-03
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Abhilasha Pharma Pvt. Ltd. in Ankleshwar, India, an API manufacturer, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate investigations of market complaints and deviations, insufficient cleaning validation for sterile API manufacturing equipment, and a lack of scientifically sound laboratory testing procedures for critical components and APIs. These issues indicate a serious lack of control over product quality and potential risks to sterile drug products distributed to the US.

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [J'Maica J. Hunter](https://www.keypedia.com/people/jmaica-j-hunter/173f731f-4dc4-4ef2-8cb3-72993cb91119)

Company: https://www.keypedia.com/companies/abhilasha-pharma-private-ltd/7e5981f3-47d3-495d-b39e-ae345fa106b9

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3