IMPRIS corrects IMRIS Neuro III-SV models due to the potential of ice blockage in the helium venting pipe
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Upcoming EL-PFDD Meetings
Upcoming EL-PFDD MeetingsMeds for Vets. Sandy, UT. 483 issued 02/21/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 02/21/2025
Short Title (70 char) Meds for Vets. Sandy, UT. 483 issued 02/21/2025
FEI Number 3003829708
Firm Name Meds for Vets
Record Type 483
State UT
Establishment Type Producer of Sterile & Non-sterile Drug PAmneal Pharmaceuticals, LLC. Issues a Nationwide Voluntary Recall of Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL, Due to the Potential for Some Bottles to be Super Potent Which May be Harmful
Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can resDr. Reddy’s Laboratories, Mirfield, West Yorkshire, UK 9.1-9.5.25_483
Record Date: 09/05/2025
Entity Name: Dr. Reddy’s Laboratories (EU) Ltd.
FEI Number: 3002807544
Record Type: 483
Country: United Kingdom
Establishment Type: API ManufacturerZhejiang Huahai Pharmaceutical Co., Ltd. – 707145 – 06/06/2025
CGMP/Finished Pharmaceuticals/AdulteratedFDA’s ISTAND Pilot Program accepts submission of first artificial intelligence-based and digital health technology for neuroscience
FDA’s Center for Drug Evaluation and Research (CDER) recently accepted a new submission into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program. This submission is the first artificial intelligence-based and digital health technology-based project and the first pro