# 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/050bbbef-54ff-4db7-9d28-27196dc2c126

> 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: Florida District Office
- Summary: This FDA Form 483 documents observations from an inspection of Jubilant Draximage Radiopharmacies Inc. dba Jubilant Radiopharma, a nuclear pharmacy located at 4205 Vineland Rd Ste L13, Orlando, FL 32811-6601. The inspection was conducted from March 5, 2024, to March 13, 2024, and the report was issued to Dr. Larry E. Jones Jr., Pharmacy Manager.

The inspection revealed six observations:

1.  **Aseptic Processing Outside ISO 5 Area:** On March 6, 2024, during Gozetotide (Illucix) Cold Kit Lot# K-20240306-069 production, the Pharmacy Manager performed aseptic connections (connecting sterile (b)(4) to the Gallium Generator and sterile (b)(4) to the Gallium Generator) in the ISO-7 aseptic processing area, not the required ISO 5 area.
2.  **Blocked "First Air" in ISO 5 Area:** On March 6, 2024, during the same Gozetotide production, the Pharmacy Manager was observed blocking first pass air in the ISO-5 (b)(4) flow hood.
3.  **Use of Non-Sterile Disinfecting Agents and Cleaning Pads:** The firm uses

## Related Documents

- [483 - 2024-03-13](https://www.keypedia.com/records/483/jubilant-draximage-radiopharmacies-inc-dba-jubilant-radiopharma/5726eeaf-32a4-41a3-976e-ea209bf9f862)
- [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/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9