Purge pressure issues found with Automated Impella Controller
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes...Chengdu Brilliant Biopharmaceutical Co., Ltd. – 711330
Delivery Method: Via Electronic Mail Return Confirmation Requested Reference #: 320-25-109 Product: Drugs Recipient: Recipient Name Mr. Zeng Dong Recipient Title General Manager Chengdu Brilliant Biopharmaceutical Co., Ltd. #33, Tengfei 12th Rd, Southwest Airport...Lee K of NY Issue Allergy Alert on Undeclared Allergen (Milk and Shrimp) in “Stewed Aged Kimchi w/Mackerel”
Summary Company Announcement Date: September 08, 2025 FDA Publish Date: September 23, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Potential or Undeclared Allergen – Milk and Shrimp Company Name: Lee K of NY INC...General Principles of Software Validation
Docket Number: FDA-1997-D-0029 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Devices and Radiological Health This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be...motionpharmacy.com – 715595 – 09/10/2025
Recipient: motionpharmacy.com United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States FROM: The United States Food and Drug AdministrationRE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over...FDA-TRACK: Biosimilar User Fee Act Procedural Notification Goals Summa
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect fees for biosimilar biological products from October 2023 through September 2027. FDA dedicates...cheaptrustedpharmacy.com – 705501 – 07/29/2025
Recipient: cheaptrustedpharmacy.com Turks & Caicos Islands Issuing Office: Center for Drug Evaluation and Research (CDER) United States FROM: The United States Food and Drug AdministrationRE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United...FDA-TRACK: Biosimilar User Fee Act Meeting Goals Summary
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect fees for biosimilar biological products from October 2023 through September 2027. FDA dedicates...Click To Verify Security & Validation
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