CGMP/Finished Pharmaceuticals/Adulterated
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FDA Publishes Filing Checklists to Prevent Submission Delays
The U.S. Food and Drug Administration today made public filing checklists used internally by Center for Drug Evaluation and Research (CDER) staff to determine if a submitted application is complete and reviewable.JKR Pharmacy Ventures, LLC dba Doc Lane’s Veterinary Pharmacy. Lexington, KY. 483 issued 12/19/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 12/19/2025
Short Title (70 char) JKR Pharmacy Ventures, LLC dba Doc Lane’s Veterinary Pharmacy. Lexington, KY. 483 issued 12/19/2025
FEI Number 3033262505
Firm Name JKR Pharmacy Ventures, LLC
Record Type 483
StaBlood Products Administration Set Recall: Fresenius Kabi Removes Large Volume Pump Blood Products Administration Sets due to Incorrect Assembly
Blood Products Administration Sets recalled due to incorrect assembly. Use may lead to administration of unfiltered blood or delays in therapy.CDER Small Business & Industry Assistance (SBIA)
A Comprehensive Resource for Information on Human Drug Development in RegulationHans Kissle LLC Issues Allergy Alert on Undeclared Wheat (Allergen) in Hans Kissle Red Potato Bliss Salad
Haverhill, MA — Hans Kissle is voluntarily recalling 66 units of Hans Kissle Red Potato Bliss Salad due to undeclared allergen (wheat). People who have an allergy or severe sensitivity to wheat run the risk of serious or life-threatening allergic reaction if they consume these products.Alvotech HF – 07/04/2025
Alvotech HF – 07/04/2025. Country: Iceland. Record Type: 483