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Pleasanton, CA | July 10, 2018: FDAzilla, a global leader in FDA intelligence and analytics, announced the addition of Patty Harvey as Food Product Manager this past February — further filling out its team of industry professionals to include a nationally recognized speaker and food expert. Patty, raised in Milpitas, CA and currently residing in […]

In the past 3 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=14] Like This & Want More? Sign up to get free […]

This is a particularly spare week for warning letter publication. There is only 1 to an API manufacturer, and we cover it below. DRUGS: Henan Lihua Pharmaceutical Co. Ltd (China) received a warning letter on June 21st, 2018 based on the outcome of an inspection ending December 14th, 2017. The firm manufactures APIs and was […]

Laws, Regulations, Guidance, and Concept Papers: Guidance documents this week were from the FDA, EMA, and HPRA.Among the FDA ones are 2 programs where FDA will further pursue and investigate criteria for their Quality metrics program.The non-guidance documents include publications from MHRA, EMA, FDA, TGAA, and ICH. Several are worth a serious read. Enforcement: By […]

Today I’d like to show you how to do supplier monitoring and benchmarking using FDAzilla Enforcement Analytics. We’ll start with a simple example of API manufacturers located outside of the United States. [NOTE: Don’t have access to FDAzilla Enforcement Analytics? Get your personalized CMO/Supplier Assessment using the techniques discussed in this article here.] Supplier Monitoring […]

FDA posted 15 warning letters this week — many issued by the Center for Tobacco Products, and 3 issued for firms in the areas we cover. GLP STUDIES, BIMO: Benedict S. Kiao, MD, at the Oeyama-Moto Medical Group Foundation, Inc (West Covina, CA) received a warning letter dated May 21st, 2018, based on the outcome […]

Laws, Regulations, Guidance, and Concept Papers: Lots of PIC/S guidance this week along with a couple from the FDA and EMA and 1 each from MHRA and HPRA.FDA’s withdrawal of a draft biosimilar guidance is in response to industry concerns about the bar that was set in establishing biosimilarity over time. It will be interesting […]

A slow warning letter week, 3 from the Center for Tobacco Products and 1 issued to a pharma manufacturer that we address below: Taiwan Biotech Company Ltd (Taiwan R.O.C.) received a warning letter dated May 31st, 2018 based on the outcome of an inspection ending on September 11th, 2017. The firm manufactures over-the-counter drug products. […]

Laws, Regulations, Guidance, and Concept Papers A busy week on the guidance publication front for FDA, WHO, HPRA, and Health Canada. A busy weekend of reading material! Among the most important from the FDA is the 21-page item on alternative mechanisms for complying with the GMPs for combination products.The non-guidance area includes the usual collection […]

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=11 ] Like This & Want More? Sign up to get […]