FDA Enforcement Trends

Week of July 1st 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 6 warning letters this week, including 1 to a finished pharma firm, 1 to an API manufacturer, and 1 to a compounding pharmacy. We cover these 3 below: DRUGS: Foshan Jinxiong Technology Co., Ltd. (Guangdong, China) received a warning letter on June 26th 2018 based on the outcome of an inspection ending August 18th 2017. The firm [...]

Week of June 24th 2018 | FDA Sent These Warning Letters to Pharma Companies

This is a particularly spare week for warning letter publication. There is only 1 to an API manufacturer, and we cover it below. Want to see the complete list of enforcement documents — including recalls, alerts, and import alerts from this week? Start your FREE trial of the GMP Regulatory Newsletter today. DRUGS: Henan Lihua Pharmaceutical Co. Ltd (China) received [...]

Week of June 17th 2018 | FDA Sent These Warning Letters to Pharma Companies

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 of an inspection conducted [...]

Part 1: Drug GMP Warning Letters Data Governance and Data Integrity

This Special Report represents the 3rd year that we have published an evaluation of warning letters associated with data governance and data integrity deficiencies. Failures in data integrity and data governance is an enforcement area that began almost 20 years ago and continues to increase in visibility and number of warning letter enforcement actions. FDA is not the only [...]

Week of June 10th 2018 | FDA Sent This Warning Letter to a Pharma Company

A slow warning letter week, 3 from the Center for Tobacco Products and 1 issued to a pharma manufacturer that we address below: Want to see the complete list of enforcement documents — including recalls, alerts, and import alerts from this week? Start your FREE trial of the GMP Regulatory Newsletter today. Taiwan Biotech Company Ltd (Taiwan R.O.C.) received a [...]

How to Do A Keyword Search in FDA Warning Letters

Want to learn how to do a keyword search in FDA warning letters? Watch the video or read the post below. We have about 15,000 warning letters in our database. You can search on any term or combination of terms in any of these documents. As an example, I’m going to search for “media fills”...

Week of June 3rd 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA warned 9 firms that operate a total of 53 websites to stop illegally marketing unapproved versions of opioid medications. FDA reminds the public that no one is authorized to sell or distribute opioids via the internet, with or without a prescription. A total of 17 warning letters were posted this week. We cover 3 of them below. DRUGS [...]

FINAL Part 3: The FDA and MHRA’s Most Recent Drug Inspection Observations

Continued from Part 1 and Part 2... MHRA Inspection Deficiencies I won’t reproduce the graphics from the MHRA slide deck; do read those because they contain a wealth of information at a granular level. Figure 3A shows the distribution of deficiencies among the 3 classifications by actual number for 2015 and 2016. Figure 3B shows this distribution of deficiencies among [...]

Week of May 27th 2018 | FDA Sent These Warning Letters to Pharma Companies

The FDA posted 6 warning letters this week, 3 of which address human drug manufacturers. Two of these 3 manufacture OTC drug products. We continue to provide the information that FDA requests firms to provide because this provides a roadmap for FDA expectations -- invaluable information for those firms that may find themselves with similar challenges. DRUGS: Jalco Cosmetic [...]