Inspection (procedure)

Exclusive: Compounding giant Empower Pharmacy cuts hundreds of staff, stops New Jersey operations

1 month ago talkbio0Tagged compounding pharmacy, East Windsor facility, Empower Pharmacy, Facility (object), Glucagon-Like Peptide 1, Inspection (procedure), layoffs, manufacturing shutdown, New Jersey operations, Outsourcing, Qualitative form, United States Food and Drug Administration, Workforce reduction

Empower Pharmacy; compounding pharmacy; layoffs; job cuts; New Jersey operations; East Windsor facility; manufacturing shutdown; outsourcing facility; FDA inspection; Form 483; compounded GLP-1 drugs; workforce reduction

FDA Issues Import Alerts for Two Chinese API Manufacturers Following Failed Inspections

12 months ago talkbio0Tagged alpha 1-antitrypsin, Chengdu, Chinese Language, Dosage Forms, Failed, import alert, innovation, Inspection (procedure), manufacturers, Quality, Science of Chemistry, United States Food and Drug Administration, Wuhu

FDA, import alert, Chinese API manufacturers, failed inspections, quality control, Wuhu Nuowei Chemistry, Chengdu Innovation Pharmaceutical

Zealand’s Hypoglycemia Drug Faces Second FDA Rejection Due to Manufacturing Issues

1 year ago talkbio0Tagged CDMO, Congenital MeSH qualifier, dasiglucagon, Hyperinsulinism, Hypoglycemia, Inspection (procedure), Rejection (Psychology), United States Food and Drug Administration, Zealand Pharma

Zealand Pharma, FDA rejection, dasiglucagon, congenital hyperinsulinism, hypoglycemia, CDMO inspection