Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection
Similar Posts
Manual Resuscitator Recall: Ambu Inc. Removes SPUR II Resuscitators Due to Blocked Manometer Port
A blocked manometer port on the Ambu SPUR II resuscitator may delay ventilation or cause barotraumaE2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety ReportsRecall Alert: Glycar SA Removes Pericardial Patch
Certain SJM Pericardial Patches from Glycar SA may not meet the required tensile strength specificationSprout Organics Expands Voluntary Recall of Sweet Potato Apple and Spinach to Include Additional Lot Codes
Sprout Organics is expanding its September 16, 2025 recall of Sprout Organics® Sweet Potato Apple and Spinach, due to potentially elevated lead levels, to include additional lots.GDUFA Implementation Quarterly Meetings between FDA and Industry
FDA and representatives of the generic drug industry meet quarterly to discuss topics related to the implementation of GDUFA.Convenience Kit Recall: Medline Industries, LP, Removes Medline Neonatal and Pediatric Kits containing Smiths Medical ORAL/NASAL Endotracheal Tubes Due to Smaller Than Expected Tube Diameter That May Cause Underventilation
Medline Neonatal and Pediatric convenience kits that include Smiths Medical ORAL/NASAL Endotracheal Tubes are used for intubation.