CGMP/Finished Pharmaceuticals/Adulterated
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Astellas Pharma Inc. – 06/06/2025. Country: Japan. Record Type: 483Winder Laboratories, LLC – 718601 – 01/07/2026
CGMP/Finished Pharmaceuticals/AdulteratedHartford Bakery, Inc. Issues Allergy Alert on Undeclared Hazelnuts in “Lewis Bake Shop Artisan Style ½ Loaf”
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CGMP/Finished Pharmaceuticals/AdulteratedJKR 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
StaPromotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers
The guidance addresses questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing FDA-regulated promotional labeling and advertisements for prescription reference products, biosimilar products, and interchangeable biosimilar products.
