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Thursday, October 19, 2017

Warning Letter due to Deficiencies in Filling System Design/Testing Particulate Matter













The US FDA has issued Warning letter in month of July 2017 to an Italian manufacturer of sterile products in Rome, due to deficiencies in the design of the filling system as well as the testing for particulate matter.

The FDA inspectors noticed that below deficiencies…

1.    Smoke studies in the filling area showed turbulent airflow. 
2.    There's no testing of the product for particulate matter before release.
3.    Sterility testing


The FDA now expects the manufacturer to identify all possible contamination risks in his aseptic production, including analyses of the facility layout, personnel and material flow, air systems and ergonomics of the equipment.

The FDA observations as below…

1.     Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).
2.     Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
3.     Sterility testing




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