Softgel Healthcare Private LimitedFebruary 22, 2019

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

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Record Details

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.

Company: Softgel Healthcare Private Limited
Inspection Date: February 22, 2019
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Felix Maldonado (Chemist at US Department of Health and Human Services)

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ID · 2cf6005d-fba7-4d5f-b320-9ccdd0b293db