Microbiology FDA 483 (Boothwyn Pharmacy): Smoke studies were inadequately performed under dynamic conditions

Observation

Smoke studies were inadequately performed under dynamic conditions

Facility Type

Sterile Manufacturing

Firm / Company

Boothwyn Pharmacy LLC

System

Quality System, Laboratory Controls, Facility and Equipment System

Details

Specifically,

Unidirectional airflow was not verified under dynamic operational conditions representative of your aseptic processing practices. Air visualization studies (“smoke studies”) performed in your ISO 5 classified biological safety cabinet (***) and in your ISO5 classified laminar airflow workbench (***) in June 2023 do not demonstrate the movement of first air around equipment, supplies, or operator manipulations as observed during sterile product operations. Your technician was observed blocking first air making it difficult to observe its movement within the ISO5 area and did not complete *** activities which is part of production as observed during the production of Alprostadil/Papaverine HCl/Phentolamine Mesylate (Tri-Mix) lot ***@ ***.

Record Date

03/2024

FEI Number

1000076625

Country

Pennsylvania

Citation Type

483

Audit Duration (Days)

8

Investigators

Christina K Theodorou
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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