Pharmaceutical Quality/Manufacturing Standards (CGMP)
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Buying & Using Medicine Safely
The information in this section can help you work with your health professionals to make the best medicine choices, buy safely, and use medicine so it’s as safe and effective as possible.Fresenius Kabi Compounding LLC. Canton, MA. 483 issued 11/05/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/05/2025
Short Title (70 char) Fresenius Kabi Compounding LLC. Canton, MA. 483 issued 11/05/2025
FEI Number 3013438665
Firm Name Fresenius Kabi Compounding LLC
Record Type 483
State MA
Establishment Type OutsoAbbreviated New Drug Application (ANDA)
Abbreviated New Drug Applications and following the path to generic drug approval. Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicantsLil’ Turtles Issues a Voluntary Recall Due to Undeclared Milk Allergen
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