# FDA 483 - Jubilant DraxImage Radiopharmacies Inc. dba Jubilant Radiopharma - March 13, 2024

Source: https://www.keypedia.com/records/483/jubilant-draximage-radiopharmacies-inc-dba-jubilant-radiopharma/5726eeaf-32a4-41a3-976e-ea209bf9f862

> FDA 483 for Jubilant DraxImage Radiopharmacies Inc. dba Jubilant Radiopharma on March 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jubilant DraxImage Radiopharmacies Inc. dba Jubilant Radiopharma
- Inspection Date: 2024-03-13
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Jubilant DraxImage Radiopharmacies Inc. dba Jubilant Radiopharma, a nuclear pharmacy in Orlando, FL, was cited for multiple deficiencies during an FDA inspection. Observations included personnel performing aseptic processing outside of ISO 5 areas, inadequate environmental controls, and insufficient quality assurance practices. These issues collectively indicate a lack of control over conditions critical to maintaining product sterility.

## Related Documents

- [483 - 2024-03-13](https://www.keypedia.com/records/483/jubilant-draximage-radiopharmacies-inc-dba-jubilant-radiopharma/050bbbef-54ff-4db7-9d28-27196dc2c126)
- [STATE_REFERRAL_LETTER - 2024-03-05](https://www.keypedia.com/records/state_referral_letter/jubilant-draximage-radiopharmacies-inc-dba-jubilant-radiopharma/346932fd-cc5c-479b-9880-d75e73385584)

## Related Officers

- [Owner/Inspector](https://www.keypedia.com/people/jared-p-stevens/11cd48ff-e61f-4448-98be-efe2f8377fc1)
- [Pharmacy Compounding National Expert at FDA](https://www.keypedia.com/people/jessica-p-mcalister/d892c069-d283-4bb0-9cbb-78e463bfc1ea)

Company: https://www.keypedia.com/companies/jubilant-draximage-radiopharmacies-inc-dba-jubilant-radiopharma/143d8ee9-878e-4e0a-9508-c1fb809dabb1

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6