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New synthesized data shows that total warning letters continued to climb in 2017. Outside the US Of course, this is part of the on-going trend of increased international inspection activity as the FDA “catches up” with the reality that 80% of all active pharmaceutical ingredients (APIs) for the US market is manufactured in either India […]

Guidance documents are available from the FDA and EMA this week across a variety of topics. Lots to read there from both the FDA and EMA. Enforcement publications were busy this week: 3 drug warning letters from FDA (2 were to OTC manufacturers)2 reports of EU GMP non-compliance2 forms 483 from sites in India A collection […]

Maybe back to more normal with 16 warning letters posted this week: The Center for Tobacco Products issued 9 warning letters3 were issued to manufacturers of finished pharmaceuticals (all are OTC manufacturers located outside the US)2 were issued to compounding pharmacies So far in CY2018, 14 warning letters out of a total of 33 drug […]

Laws, Regulations, Guidance, and Concept Papers FDA published several new guidance, both draft and final, this week: 2 are administrative2 address quality1 addresses format for submission of vaccines dataBonus excellent publication: ICH Q&A regarding Q7. It includes just under 60 questions and an appendix that links each Q&A to the section of Q7. TGA published […]

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. [supsystic-tables id=7 ] Like This & Want More? Sign up to get […]

FDA posted 10 warning letters this week: Several for misbranded drugs2 in the drug area:1 for a finished drug manufacturer1 for a compounding pharmacy Note the FDA ‘requests’ that the firm must respond to. These always provide a roadmap for the type of activities expected of manufacturers who might find themselves with similar challenges. Free […]

Laws, Regulations, Guidance, and Concept Papers A bit of a busier week than last week for guidance: The FDA published 6 documents.Nothing from EMA in the areas we follow.WHO, CDSCO, Health Canada, TGA, and HPRA also published guidance. Non-guidance publications from the usual sources MHRA, EMA, FDA. Also of interest is 1 each from TGA […]

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. [supsystic-tables id=6 ] Like This & Want More? Sign up to get […]

Laws, Regulations, Guidance, and Concept Papers It’s been a slow week all around, perhaps spring breaks and the holidays? Among the non-guidance publications, CFDA published an update on their 2017 Review Metrics. Enforcement A very slow enforcement week: FDA published only 2 warning letters.Nothing from Europe.We do see the usual collection of drug recalls and […]

Pleasanton, CA | April 9, 2018: FDAzilla, a global leader in FDA intelligence and analytics, announced the addition of Jamie Colgin as GCP Product Manager — further filling out its team of industry experts to include a GCP and data integrity professional. Jamie, hailing from Moorpark, CA and recipient of the prestigious Charles H. Butler Excellence […]