Recent 2018-04-18T11:36:52+00:00


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 [...]

How Do I Apply ALCOA To E-Records?

It’s easier than you think! Let’s... Start with a paper record example Explore how to apply ALCOA to electronic records Point out 3 warning signs on the trail to data integrity ALCOA in the Paper World ALCOA defines the generally accepted standard for GLP and GCP data quality and data integrity. Let’s use [...]

By | June 21st, 2018|Categories: Biopharma / Pharma, CGMP, FDA Inspections, Medical Devices|0 Comments

GMP Regulatory Newsletter: Summary Scan | Week of 6/10/18

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. [...]

By | June 20th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|0 Comments

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”...

86 New FDA 483s | June 18th 2018

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. Like This & Want More? Sign up [...]

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 [...]

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 [...]

GMP Regulatory Newsletter: Summary Scan | Week of 6/3/18

Laws, Regulations, Guidance, and Concept Papers: A handful of guidance documents published this week from the FDA, EMA, and ICH. The usual collection of non-guidance documents also published including several slide decks from presentations made by EMA representatives. To see the complete list of laws, regulations, guidance, and concept [...]

By | June 13th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|0 Comments

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