CGMP/Finished Pharmaceuticals/Adulterated
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Bulk Drug Substances Used in Compounding
Compounders sometimes produce drugs using bulk drug substances or active pharmaceutical ingredients. Because compounding from these substances presents risks to patients, sections 503A and 503B of the FD&C Act place limits on the bulk drug substances that can be used in compounding.The Goat may be harmful due to hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use The Goat, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.Olympia Pharmaceuticals. Orlando, FL. 483 issued 08/08/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 08/08/2025
Short Title (70 char) Olympia Pharmaceuticals. Orlando, FL. 483 issued 08/08/2025
FEI Number 3009724085
Firm Name Olympia Pharmaceuticals
Record Type 483
State FL
Establishment Type Outsourcing FaciliEarly Alert: Heart Pump Purge Cassette Issue from Abiomed
Impella Generation 1 Purge Cassettes have an increased risk of purge leaks. Purge leaks can lead to low pump pressure and pump stopsLaboratory Information Bulletins
Laboratory Information Bulletins available to the publicEugia Pharma Specialities Limited – 681905 – 08/15/2024
CGMP/Finished Pharmaceuticals/Adulterated