Microbiology FDA 483 (Jubilant Radiopharmacies): The movement of first air in the ISO 5 area is blocked or disrupted

Observation

Personnel were observed conducting aseptic manipulations where the movement of “first air” in the ISO 5 area is blocked or disrupted

Facility Type

Sterile Manufacturing

Firm / Company

Jubilant DraxImage Radiopharmacies Inc.

System

Details

Specifically, on 03/06/24, during the production of Gozetotide (Illucix) Cold Kit Lot# K-***, your firm’s Pharmacy Manager was observed blocking first pass air in the ISO-5 *** flow hood. The following prescriptions were drawn from the cold kit and dispensed: RX*** (13.94 mCi) and RX*** (25.49 mCi).

Record Date

05/2024

FEI Number

3009339218

Country

Florida

Citation Type

483

Audit Duration (Days)

6

Investigators

Jessica P Mcalister, Jared P Stevens
FDA 483 relevant to Microbiology

Disclaimer: The purpose of this article is to provide helpful information on FDA 483s related to microbiological issues. This article represents 483 information in Tabular form for quick access and easy navigation. Information for this article is derived from “Form FDA 483” (Inspectional Observation). This article is not intended to replace the information provided by the FDA, nor is it guaranteed to be complete, always refer official FDA site for details.

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