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  • Issue 1014 April 15, 2019 Issue 1014 April 15, 2019

    Highlights actual 483 observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers.  This issue features observations from sterile manufacturing facilities. Highlights actual 483 observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers.  This issue features observations from sterile manufacturing facilities.
    $49.99
  • Issue 1013 April 1, 2019 Issue 1013 April 1, 2019

    Highlights actual 483 observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers.  This issue features observations pertaining to packaging and labeling. Highlights actual 483 observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers.  This issue features observations pertaining to packaging and labeling.
    $49.99
  • Quarterly Special Issue QSI-19Q2 - Production and Process Controls Quarterly Special Issue QSI-19Q2 - Production and Process Controls

    This is a comprehensive 6 page report on observations pertaining to 21 CFR 211 Subpart F  and 21 CFR 820 Subpart G - Production and Process Controls.  There are observations on deviations,... This is a comprehensive 6 page report on observations pertaining to 21 CFR 211 Subpart F  and 21 CFR 820 Subpart G - Production and Process Controls.  There are observations on deviations,...
    $59.99
  • List of FDA Inspected Facilities Q4-2018 List of FDA Inspected Facilities Q4-2018

    A summary of FDA Inspections that were conducted between October 1, 2018, and December 31, 2018.  The report includes whether or not facility received a 483, length of inspection and... A summary of FDA Inspections that were conducted between October 1, 2018, and December 31, 2018.  The report includes whether or not facility received a 483, length of inspection and...
    $199.00
  • Annual Report of FDA Observations FY 2018 Annual Report of FDA Observations FY 2018

    A comprehensive annual overview of the most frequently cited cGMP violations from actual FDA inspections. This 30-page report graphically depicts inspection observations by category and provides specific detail from actual... A comprehensive annual overview of the most frequently cited cGMP violations from actual FDA inspections. This 30-page report graphically depicts inspection observations by category and provides specific detail from actual...
    $299.00
  • Issue 1012 March 15, 2019 Issue 1012 March 15, 2019

    Highlights actual 483 observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers.  This issue features observations pertaining to Data Integrity. Highlights actual 483 observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers.  This issue features observations pertaining to Data Integrity.
    $49.99
  • Issue 1011 March 1, 2019 Issue 1011 March 1, 2019

    Highlights actual 483 observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers.  This issue features observations from active pharmaceutical ingredient manufacturers. Highlights actual 483 observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers.  This issue features observations from active pharmaceutical ingredient manufacturers.
    $49.99
  • FDA Inspection Guideline FDA Inspection Guideline

    This comprehensive 17 slide guideline provides practical "how to" advice for any organizations subject to FDA regulatory review. The guideline draws from more than 50 years of regulatory expert opinion... This comprehensive 17 slide guideline provides practical "how to" advice for any organizations subject to FDA regulatory review. The guideline draws from more than 50 years of regulatory expert opinion...
    $24.99

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