2018 MHRA GMP Inspection Deficiencies
Provided is an overview of MHRA’s 2018 GMP inspection deficiencies parsed by Annex and Chapter, and Critical and Major deficiencies.
Barbara W. Unger
December 5, 2019
FDA Warning Letters Week of 11/24/2019: Repackaging and CBD Products
FDA posted one warning letter to a pharmaceutical firm and 15 to firms that sell CBD products.
Barbara W. Unger
December 3, 2019
October 2019: FDA Warning Letters to Food Companies
We took a snapshot of the seven warning letters FDA sent to food and dietary supplement companies that were posted in October. Violations range from misbranding to the presence of Listeria monocytogenes.
Patty Harvey
November 26, 2019
FDA Warning Letters Week of 11/17/2019: Torrent (Again) and Failing Water Systems
We cover the three FDA warning letters published this week including the second one to Torrent Pharmaceuticals in October 2019.
Barbara W. Unger
November 26, 2019
Upcoming Webinar: GMP Compliance Issues for Legacy Products
Join FDAzilla’s GMP Quality Expert Jerry Chapman for an informative 1-hour webinar on assessing legacy products for potential GMP compliance gaps and pitfalls.
FDAzilla
November 20, 2019
FDA Warning Letters Week of 11/10/2019: FD&C Act and Continued Sartan Enforcement
A busy week for enforcement. Included in this week of warning letters are Dollar Tree (in which FD&C Act is cited rather than CFR), Cadila Healthcare Limited, and Mylan Laboratories Limited among others.
Barbara W. Unger
November 19, 2019
October 483s: Most Popular and Newsworthy
We put together a review of notable 483s from the month of October, including 483s posted by FDA throughout the month and most-purchased 483s from the FDAzilla Store.
Jessica Strmiska
November 13, 2019
FDA Warning Letters Week of 11/3/2019: Lost Documentation and Data Integrity
Yet another week with a preponderance of warning letters issued by the Center for Tobacco Products. We cover one warning letter issued to an OTC manufacturer in China.
Barbara W. Unger
November 12, 2019
FDA Warning Letters Week of 10/27/2019: Sterility and Spores
A slow week for drug and device warning letters as FDA continues their enforcement focus on e-cigarette suppliers. Enforcement this week includes a lone GMP warning letter to a PET drug manufacturer.
Barbara W. Unger
November 5, 2019