FDA
DSCSA Pharmaceutical Serialization Updates and New Guidance
The Drug Quality and Security Act (DQSA) was enacted by Congress on November 27, 2013. Title II of this act was the Drug Supply Chain Security Act (DSCSA) to enhance the FDA’s ability to protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The requirements also included improvements for the…
Read MoreCosmetic GMPs and MoCRA
Updated Requirements for Cosmetic Companies MoCRA enacts the most significant expansion of the US FDA to regulate cosmetics since 1938. After 85 years of being effective, the Modernization of Cosmetics Regulation Act of 2022 , also known as “MoCRA” has been updated. It was enacted by Congress as part of the 4,155 pages of the Consolidated…
Read MoreTop 2018 FDA Inspection Observation Categories
Each year the FDA provides spreadsheets summarizing the areas of regulation cited in these observations at the following website: FDA.gov The spreadsheets are not a comprehensive listing of all observations but represent the a number of times it was cited as an observation on a FDA Form 483. Top categories for 2018: #1 Quality…
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