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# Liva Pharmaceuticals FDA-483
- URL: https://www.fdaweb.com/liva-pharmaceuticals-fda-483/
- Published: 2018-09-12T12:00:00.000Z
- Updated: 2026-09-15T00:31:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142337

FDA has released the FDA-483 issued following an 8/20-8/28 inspection at Liva Pharmaceuticals, Gujarat, India. The [document](ttps://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM619913.pdf) lists these inspection observations: 

- procedures designed to prevent microbiological contamination of sterile small volume parenteral drug products purporting to be sterile are not followed;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- employees engaged in the manufacture, processing, and packing of a sterile small volume parenteral drug product lack the training and experience to perform their assigned functions;
- failing to follow established and approved standard operating procedures; and
- investigation invalidating an out-of-specification during the real-time stability studies is not scientifically justified.