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A compilation of relevant 483 observations edited for significance. The report covers observations for manufacturing controls, laboratory controls, and medical device controls. Each issue also features a rotating category. These rotating categories include Sterile manufacturing controls, active pharmaceutical ingredient manufacturing controls, packaging and label controls and data integrity.
Quarterly Facility List
A summary of drug and device facilities that were inspected by the US FDA during a certain quarter. The report includes domestic and foreign inspections. The report is in excel format and allows for sorting based on selected criteria. It includes whether or not a facility received a 483, the time duration of the inspection and CFR citations where available.
Quarterly Special Topics Report
The GMP Trends Special Topics quarterly report expands on the bi-monthly report by focusing on just one specific topic regardless of industry. Special Topic reports contain observations about change control, validation, stability, etc.
The GMP Trends® Annual Report is a review of FDA Inspection Observations for the previous Fiscal Year. The report includes examples of cited observations from actual Form 483s, trends of top-cited observations for Drug and Device Facilities. The report is published in the first quarter of the year.