Category: CGMP

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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