Objectionable Bacillus spp. Found During Customer Sampling During the FDA’s inspection of VUAB Pharma a.s., Vltayska 53, Roztoky, Czech Republic, from June 09, 2014, through June 13, 2014, an investigator from the U.S. Food and Drug Administration (FDA) identified significant deviations from current good manufacturing practice (CGMP) for the … [Read more...]
VUAB PHARMA, CZECH REPUBLIC, RECEIVES WARNING LETTER (MAY 27, 2015)
Objectionable Anaerobe Found During Customer Sampling During the FDA’s inspection of VUAB Pharma a.s., Vltayska 53, Roztoky, Czech Republic, from June 09, 2014, through June 13, 2014, an investigator from the U.S. Food and Drug Administration (FDA) identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active … [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...]
ID BIOMEDICAL CORP RECEIVES WARNING LETTER (6/12/14)
COMPANY CONTINUED TO FIND GRAM NEGATIVES IN PW WATER SYSTEM ID Biomedical Corp, a subsidiary of GSK Biologicals, located in Quebec, Canada was audited by the FDA from March 31 through April 9, 2014. The FDA Investigators documented deviations from CGMP in the manufacture of their biological drug product, Flulaval and its intermediates. Significant objectionable conditions … [Read more...]
Wockhardt’s Walui and Chikalthana Facilities, Maharasthtra Receive Warning Letter (11/25/13)
Data Manipulation Continues to be a Major Issue After a somewhat quiet month, CDER is again active in India. Their current concern is with a Company that should be familiar to each of us. And the issues in many cases are similar to those found within a Warning Letter issued in July of this year. Alexander Gaffney, RAPS Editor, has put together an excellent summary of this … [Read more...]
