# FDA 483 - Softgel Healthcare Private Limited - February 14, 2025

Source: https://www.keypedia.com/records/483/softgel-healthcare-private-limited/2c136726-b094-4d42-a338-45664d0dd3c2

> FDA 483 for Softgel Healthcare Private Limited on February 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Softgel Healthcare Private Limited
- Inspection Date: 2025-02-14
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Softgel Healthcare Private Limited, a drug manufacturer in Kancheepuram District, India, was inspected by the FDA. The inspection revealed significant deficiencies in the firm's quality system, including inadequate investigations, poor quality unit control over documents and data integrity, and a lack of appropriate validation and controls for computerized manufacturing systems. These issues indicate a systemic failure to ensure product quality and data reliability.

## Related Documents

- [483 - 2019-02-22](https://www.keypedia.com/records/483/softgel-healthcare-private-limited/2cf6005d-fba7-4d5f-b320-9ccdd0b293db)

## Related Officers

- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.keypedia.com/companies/softgel-healthcare-private-limited/60e6960a-1e97-496a-8a60-afb3e124b1aa

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