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Enforcement

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Recent Posts

FDA Warning Letters Week of 3/1/2020: Device Design Controls, HCT/P

Enforcement this week included a collection of warning letters including three device warning letters and three drug GMP warning letters, including one to a fertility clinic governed under 21 CFR 1271. And, warning letters to firms touting treatments for the coronavirus disease finally started appearing.

February 483s: Most Popular and Newsworthy

We put together a review of notable 483s from the month of February, including 483s posted by FDA throughout the month and most-purchased 483s from the Govzilla Store.

The Importance of Monitoring Import Alerts

Firms that thought it wasn’t necessary to monitor import alerts that may have been placed against their suppliers received another lesson from FDA in January that they are wrong.

January 483s: Most Popular and Newsworthy

We put together a review of notable 483s from the month of January, including 483s posted by FDA throughout the month and most-purchased 483s from the Govzilla Store.

RECENT POSTS

FDA Warning Letters Week of 3/8/2020: BIMO and OTC Products

Lots of warning letters this week issued by the Center for Tobacco Products, including 22 to firms selling flavored, cartridge-based electronic cigarettes.  FDA also posted one issued to a drug manufacturer and one to a clinical investigator.  We cover the latter two here.  And, the Cipla warning letter we referenced last week has not been posted yet.

Read More »

Part 1: MHRA GMP Inspection Deficiencies for 2018

Published in late 2019, MHRA’s 2018 GMP inspection deficiency data spans over 6,000 lines of a spreadsheet. GMP expert Barbara W. Unger evaluated the data and presents a data-dense report of her findings and deficiency trends since 2015.

Read More »

FDA Warning Letters Week of 3/1/2020: Device Design Controls, HCT/P

Enforcement this week included a collection of warning letters including three device warning letters and three drug GMP warning letters, including one to a fertility clinic governed under 21 CFR 1271. And, warning letters to firms touting treatments for the coronavirus disease finally started appearing.

Read More »

RECENT POSTS

FDA Warning Letters Week of 3/8/2020: BIMO and OTC Products

Lots of warning letters this week issued by the Center for Tobacco Products, including 22 to firms selling flavored, cartridge-based electronic cigarettes.  FDA also posted one issued to a drug manufacturer and one to a clinical investigator.  We cover the latter two here.  And, the Cipla warning letter we referenced last week has not been posted yet.

Read More »

Part 1: MHRA GMP Inspection Deficiencies for 2018

Published in late 2019, MHRA’s 2018 GMP inspection deficiency data spans over 6,000 lines of a spreadsheet. GMP expert Barbara W. Unger evaluated the data and presents a data-dense report of her findings and deficiency trends since 2015.

Read More »

FDA Warning Letters Week of 3/1/2020: Device Design Controls, HCT/P

Enforcement this week included a collection of warning letters including three device warning letters and three drug GMP warning letters, including one to a fertility clinic governed under 21 CFR 1271. And, warning letters to firms touting treatments for the coronavirus disease finally started appearing.

Read More »