Health Canada Begins Publishing Information Regarding Emerging Issues As part of Health Canada's ongoing commitment to openness and transparency, the Department recently began publishing information regarding emerging issues identified through the drug inspection program. This Inspection Tracker provides a snapshot of the potential health and safety issues Health Canada … [Read more...]
Sagent Pharmaceuticals Recall due to FDA Observations Pertaining to Aseptic and GMP Practices at the Manufacturer’s Site Potentially Impacting Product Sterility
Sagent Pharmaceuticals, Inc. Schaumburg, IL announced on February 23, 2015 the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials … [Read more...]
2015 United States Pharmacopeia (USP) Microbiological Training Program — 9-Part Live Training Program Instructor: Barry A. Friedman Ph.D.
STARTS THURSDAY, MARCH 19, 2015 The United States Pharmacopeia (USP) contains a number of chapters relating to microbiology within its General and General Information Chapters. These Chapters present information that relate to both non-sterile and aseptic processing. Several of these chapters have been recently updated and all have been updated since 2009. Each of these … [Read more...]
MICRO LABS LIMITED, VERNA, INDIA RECEIVES WARNING LETTER (01/09/15)
The FDA inspected Micro Labs Limited, located at Plot No. S-155 to S-159, Phase III, Verna Industrial Estate, Verna, India, between May 5-10 and 12-13, 2014. Investigators from the U.S. Food and Drug Administration (FDA) identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal … [Read more...]
SAGENT PHARMACEUTICALS INITIATES INJECTABLE RECALL DUE TO ASEPTIC AND GMP PRACTICES (2/23/15)
Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL due to FDA Observations Pertaining toAseptic and GMP Practices at the Manufacturer’s Site Potentially Impacting Product Sterility Schaumburg, … [Read more...]
