New FDA enforcement – Data Integrity
The history
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The history
The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. The FDA (Food and Drug Administration), an agency within the US Department of Health and Human Services, was given more authority...
Since 1938, the US Food and Drug Administration (FDA) established regulations for drug manufacturers. Medical gases are considered prescription drugs and are covered by these regulations. The regulations (21 CFR Part 211) have been revised...
Producers and distributors of specialty gases in food and beverages need to know that the new regulations for the Food Safety Modernization Act (21 CFR Part 117) are now officially in effect.
The specialty gas industry is about 50 years old. During that time, there has been rapid innovation in production processes, instrumentation, cylinders, valves, distribution, and engineering. For example, Ultra High Purity (UHP, Grade 5.0) gases used to be produced in a...
