Microbiology FDA 483 (Medi-Fare Drug): Aseptic processing areas are deficient regarding the system for monitoring environmental conditions

Observation

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions

Facility Type

Sterile Manufacturing

Firm / Company

Medi-Fare Drug

System

Quality System, Laboratory Controls, Facility and Equipment System

Details

Specifically, your film utilizes *** that are not directly supplied with HEPA-filtered air and rely on a passive supply from a HEPA-filtered, ISO 7 room. This practice may allow introduction of contaminants from an unclassified space.

Record Date

03/2024

FEI Number

3009925820

Country

South Carolina

Citation Type

483

Audit Duration (Days)

8

Investigators

Jared P Stevens

More observations from same firm / company

Not applicable

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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