# FDA 483 - Softgel Healthcare Private Limited - February 22, 2019

Source: https://www.keypedia.com/records/483/softgel-healthcare-private-limited/2cf6005d-fba7-4d5f-b320-9ccdd0b293db

> FDA 483 for Softgel Healthcare Private Limited on February 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Softgel Healthcare Private Limited
- Inspection Date: 2019-02-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Softgel Healthcare Private Limited in Kancheepuram District, India, received two observations during an FDA inspection. The firm was cited for not fully following its quality control unit procedures, specifically regarding the use of unvalidated testing methods for commercial drug batches. Additionally, the facility lacked hot water in the washing and toilet facilities for the production area, posing a potential hygiene concern.

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## Related Officers

- [Chemist at US Department of Health and Human Services](https://www.keypedia.com/people/felix-maldonado/d7a5c4bd-2aa7-405f-b3c4-17ef35152ab4)

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

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1