Can I read FDA 483 Observations on Media Fill Practices on EtoBox?

FDA 483 Observations on Media Fill Practices by vijayns_250355172 is a document available to read on EtoBox.

What is FDA 483 Observations on Media Fill Practices about?

This document from the FDA lists 3 observations from an inspection of Beacon Hill Medical Pharmacy. Observation 1 notes deficiencies in their aseptic processing operations including a lack of validation of aseptic techniques, environmental monitoring, and cleaning/sanitizing practices. Observation 2 finds that equipment is not adequately cleaned and maintained to prevent contamination. Observation 3 states there are no written production control procedures to ensure drug identity, strength, quality and puri

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vijayns_250355172

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EN