Microbiology FDA 483 (Front Door Pharmacy): Blocked the movement of first pass air by personnel conducting aseptic manipulations
Observation
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Firm / Company
Front Door Pharmacy, LLC
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Details
Specifically, during the visual sterile production observation of the finished sterile drug product, P105 (PAP30MG/ PHE1MG/ PGE10MCG), Lot # 051321@***, Expiry 7/16/21 being performed by the pharmacy PIC, the following conditions were observed:
(A) Reaching over filled sterile *** unstopped vials to fill empty vials.
(B) Placed a tray of empty vials awaiting filling in between the HEPA filter and the vials undergoing ***/filling, resulting in an interruption of 1st air for the vials being processed the ISO 5 LAFU.
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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.