Category: Risk Management

FDA Warning Letters Week of 3/22/2020: OTC and HCT/P

In the areas we cover, FDA posted three drug GMP warning letters including one sent to a fertility clinic governed by HCT/P regulations.  The other two firms manufacture OTC products.  FDA also posted a warning letter to a firm in Ireland, Carahealth, for distributing unapproved and misbranded products related to coronavirus disease.

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EMA Announcements Regarding Nitrosamine and MDRs

The EMA published information on two topics this week addressing changes in due dates and application dates regarding nitrosamine-related risk assessments and implementation of the new Medical Device Regulation (MDR) requirements.

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Part 3: 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.

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Part 2: 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 3/8/2020: 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.

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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.

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