Aseptic/Sterile Processing

Jul 25, 2017
By BioPharm International Editors
FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.
Jun 26, 2017
By BioPharm International Editors
Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.
Jun 19, 2017
By BioPharm International Editors
The company has voluntarily recalled Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level because of a lack of sterility assurance.
Jun 14, 2017
By BioPharm International Editors
FDA sent a warning letter to drug compounder DCA, Inc. dba Beacon Prescriptions for failing to ensure sanitary conditions.
May 09, 2017
By BioPharm International Editors
FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.
Feb 27, 2017
By BioPharm International Editors
Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.
Feb 16, 2017
By BioPharm International Editors
FDA sent a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found deviations in the facility’s aseptic processes.
Feb 15, 2017
By BioPharm International Editors
The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.
Feb 15, 2017
By BioPharm International Editors
The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.
Feb 08, 2017
By BioPharm International Editors
Modular Automated Sampling Technology (MAST) allows direct aseptic transfer of bioreactor samples to analytical devices, providing rapid and reliable data in bioprocessing.
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