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403 Search Results Found For: "Medical Device"
[…] cited observations from actual Form 483s, trends of top-cited observations for Drug and Device Facilities.
[…] covered include manufacturing controls, laboratory controls, and medical device controls, along with a rotating category […]
A summary of FDA inspections that were conducted between January 2020 and March 2020. The report includes whether or not a caility received a 483, length of inspection and CFR citations where available.
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 483 reports.
Foreign and Domestic Drug & Device Facilities The following is a summary of FDA […]
A summary of FDA inspections that were conducted between October 2023 and December 2023. The report included whether or not the facility received a 483, the length of the inspection, and CFR citations where available.
A summary of FDA inspections that were conducted between October 2021 and December 2021. The report includes whether or not a facility received a 483, length of inspection and CFR citations where available.
[…] be submitted to the FDA as a Medical Device Report. 3 . … . . […]
Foreign and Domestic Drug & Device Facilities The following is a summary of FDA […]
A summary of FDA inspections that were conducted between April 2022 and June 2022. The report includes whether or not a facility received a 483. length of the inspection and CFR citations where available.