483
PMC Biogenix, Inc.PMC Biogenix, Inc. – FDA 483, Apr 25, 2017
Record Details
An FDA inspection of PMC Biogenix, an API manufacturer in Memphis, TN, revealed significant issues across three observations. The firm failed to validate the cleaning of truck trailers to prevent cross-contamination and exhibited deficiencies in its Quality Management Review process for Glycerin, USP. Additionally, equipment qualification was found to be inadequate, lacking demonstration of critical performance parameters.
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ID · b7fcfe1b-374d-4c3a-8925-6bf2a0d96f94
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