This draft guidance provides information on the implementation of the statutory provision that authorizes FDA to require application holders for certain drug and biological products to make labeling changes based on new safety information that becomes available after approval of the drug.
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Nephron Sc Inc. West Columbia, SC. 483 issued 08/22/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 08/22/2025
Short Title (70 char) Nephron Sc Inc. West Columbia, SC. 483 issued 08/22/2025
FEI Number 3010892830
Firm Name Nephron Sc Inc
Record Type 483
State SC
Establishment Type Sterile Drug ManufacturingBlack Panther Miracle Honey for Men may be harmful due to hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Black Panther Miracle Honey for Men, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.Denver Solutions, LLC. Englewood, CO. 483 issued 12/11/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 12/11/2025
Short Title (70 char) Denver Solutions, LLC. Englewood, CO. 483 issued 12/11/2025
FEI Number 3013438582
Firm Name Denver Solutions, LLC
Record Type 483
State CO
Establishment Type Outsourcing FacilityEarly Alert: Wound and Burn Dressing Issue from Integra LifeSciences
Integra is removing all MediHoney Wound and Burn products and certain lots of CVS Wound Gel that may have breached sterile barriersDrug Safety Communications
FDA Drug Safety Communications connect consumers and health care professionals to important drug safety information. The webpage contains the most recent Drug Safety Communications from FDA as well as links for Early Communications, Follow-Up Early Communications, Information for Healthcare ProfessiShiva Analyticals Private Limited – 707857 – 07/23/2025
CGMP/Finished Pharmaceuticals/Adulterated