Validation Times - FDA calls Iso-Tex sterility validation acceptable but stability and complaint handling lacking
July 1, 2002 -- Iso-Tex Diagnostics' responses to 483 observations concerning environmental issues were acceptable to FDA while responses to stability and...
Inspection Monitor - Iso-Tex to correct stability and complaint handling
June 1, 2002 -- Iso-Tex Diagnostics, Friendswood, TX, Dallas District Radiopharmaceutical manufacturer Iso-Tex Diagnostics ran into a haggling session with FDA...
Validation Times - Iso-Tex cited for autoclave validation, sterilization
December 1, 2001 -- The inspection of Iso-Tex Diagnostics of Friendswood, TX, netted the firm a Nov. 8 warning letter citing failure to validate autoclave cycles used to...
