# FDA 483 - Isorx Corp - September 18, 2019

Source: https://www.keypedia.com/records/483/isorx-corp/f4ff48e5-6728-4922-883e-efc34a32e74c

> FDA 483 for Isorx Corp on September 18, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Isorx Corp
- Inspection Date: 2019-09-18
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

## Related Documents

- [483 - 2019-09-18](https://www.keypedia.com/records/483/isorx-corp/ed42cf36-702a-4a47-95de-ef161c5b9874)

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/andrew-k-haack/d0e236ac-3223-43e0-8378-300de21b19f5)

Company: https://www.keypedia.com/companies/isorx-corp/2a9360d8-9a83-4491-9942-09390ffdb87f

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b