Isorx CorpSeptember 18, 2019

FDA 483 - Isorx Corp - September 18, 2019

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Record Details

Isorx, Corp. in Richmond, CA, was inspected by the FDA from September 9-18, 2019, revealing significant deficiencies in aseptic processing controls. The firm failed to properly disinfect materials and cleaning agents, and did not effectively use sporicidal agents. Additionally, the inspection found that batch production and control records for sterile drug products were incomplete and lacked essential information.

Company: Isorx Corp
Inspection Date: September 18, 2019
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West V
Person: Andrew K. Haack (Compliance Officer)

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