483
Softgel Healthcare Private LimitedSoftgel Healthcare Private Limited – FDA 483, Feb 22, 2019
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.
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ID · 2cf6005d-fba7-4d5f-b320-9ccdd0b293db
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