SISTER COMPANY OF NECC RECEIVES TWENTY PAGE 483 CONTAINING SEVERAL REPEAT OBSERVATIONS COMMENT The FDA conducted an inspection of Ameridose, LLC, Westborough, MA from October 10 through November 9, 2012. The investigation, involved fourteen Investigators and three microbiologists including one microbiologist from CDER. A total of fifteen Observations including several … [Read more...]
PYROGEN AND ENDOTOXIN TESTING: QUESTIONS AND ANSWERS (06/12) JUST ISSUED
The FDA just published their final Guidance for Industry Pyrogen and Endotoxin Testing: Questions and Answers. FDA has determined that previously published USP and AAMI documents describing methods and calculation of pyrogen and endotoxin testing limits provide industry with appropriate information. However, because the compendial chapters and standards do not address certain … [Read more...]
