Resources

FDA posted 12 new warning letters this week. Among the ones we cover one to a finished pharmaceutical firm. Goran Pharma Private Limited (Gujarat, India) received a warning letter dated April 24th, 2018 based on the outcome of an inspection ending November 15th, 2017. The firm was placed on import alert 66-40 on March 5th, […]

We continuously monitor, collect, sort, tag, and link data from multiple agencies to enable bespoke reports, user-friendly searches, and automated alerts. Equipped with this unrivaled information, you’ll reduce regulatory risk, maximize actionable insights, and minimize research time. With FDAzilla you can unlock actionable intelligence to be more effective and do more with less. Here’s […]

Laws, Regulations, Guidance, and Concept Papers A collection of both draft and final guidance: The FDA and EMA published this weekOthers also issued guidance including WHO, HPRA, Health Canada, TGA, and CDSCO. Much to read! Also, the non-guidance publications continue: MHRA, EMA, and FDA publishedAmong this later collection are the MHRA GCP Inspection MetricsChanges in […]

The FDA and Federal Trade Commission issued 13 warning letters this week to manufacturers and retailers selling e-liquids used in e-cigarettes. One of the objections was that the packaging resembles kid-friendly food products; others included selling these items to minors. FDA published 1 warning letter to a compounding pharmacy. This is a slow enforcement week […]

Laws, Regulations, Guidance, and Concept Papers Guidance documents were in modest supply this week: 4 from FDA4 from EMA2 from Health Canada2 items from PakistanFDA also withdrew 1 final rule due to “significant adverse comments” received during the comment period ending April 11th 2018. This one is important. In the non-guidance area, we have the […]

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=8 ] Like This & Want More? Sign up to get […]

FDA posted 6 new warning letters this week: The Center for Tobacco issued 3 of them1 warning letter went to an API manufacturer2 warning letters were issued to finished pharmaceuticals manufacturers of OTC products DRUGS: Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd (Yunnan, China) received a warning letter on April 19th 2018 based on the […]

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 […]