# FDA 483 - Isorx Corp - September 18, 2019

Source: https://www.keypedia.com/records/483/isorx-corp/ed42cf36-702a-4a47-95de-ef161c5b9874

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

---

## Details

- Record Type: 483
- Company Name: Isorx Corp
- Inspection Date: 2019-09-18
- Product Type: Drugs
- Office Name: San Francisco District Office
- Summary: On September 18, 2019, the FDA issued a Form 483 to Isorx, Corp., a producer of sterile and non-sterile drugs located at 845 Marina Bay Parkway, Suite 9, Richmond, CA 94804, following an inspection conducted from September 9-18, 2019. The report was issued to Michael J. Whyte, Owner.

The inspection revealed four observations:

1.  **Materials or supplies were not disinfected prior to entering aseptic processing areas.** On September 11, 2019, a pre-sterilized/depyrogenated syringe was removed from the ISO 5 laminar flow hood and cleanroom, exposed to unclassified air, and then returned to the ISO 5 hood for the production of I-123 Metaiodobenzylguanidine (MIBG) USP, Rx (b)(4), lot 119141 MIBG, a sterile drug product.

2.  **Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.** On September 11, 2019, non-sterile wipes were used for pre-operational cleaning of the ISO 5 laminar flow hoods, which were used to produce I-123 Metaiodobenzylguanidine (MIBG) Rx (b)(4), lot

## Related Documents

- [483 - 2019-09-18](https://www.keypedia.com/records/483/isorx-corp/f4ff48e5-6728-4922-883e-efc34a32e74c)

## 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/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df