FDA Enforcement Trends

28 03, 2018

The FDA’s “One Quality Voice”

By | 2018-03-28T13:46:24+00:00 March 28th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDAzilla|

FDA’s report on pharmaceutical quality for the 21st Century in 2004 put forth their vision for reorganization within the FDA that would strengthen their ability to ensure drug quality. As part of FDA’s reinvention and modernization, they created the Office of Product Quality ‘to promote “One Quality Voice” through the integration of review, inspection, surveillance, policy, and research for [...]

27 03, 2018

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

By | 2018-04-10T13:28:55+00:00 March 27th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDAzilla, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers We have another slow week in the publication of guidance: FDA published 2 addressing post approval safety reporting for combination products and 1 regarding drug compounding EMA published 1 item addressing pharmacogenomic practices CDSCO (India) and TGA each published 1 We see the usual collection of non-guidance items from MHRA, EMA, FDA, and [...]

26 03, 2018

33 New FDA 483s | March 26th 2018

By | 2018-04-04T16:48:51+00:00 March 26th, 2018|Biopharma / Pharma, FDA Enforcement Trends, FDAzilla, Food, Medical Devices, Weekly FDA 483s|

Last week, 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 to get free weekly content updates designed to make your job easier. Learn [...]

20 03, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 3/11/18

By | 2018-03-20T10:25:51+00:00 March 20th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters, FDAzilla, Form FDA 483, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers It’s a very light week for new guidance documents, but do note that the FDA has two in the area of tobacco. The non-guidance publications include the usual collection from FDA, EMA, MHRA, HPRA, and TGA. The FDA also released the form 483 for a recent publication of Biocon’s facility in Malaysia. Want [...]

19 03, 2018

CDRH Planned Reorganization Breaks Down Silos and Focuses Expertise by Product Type

By | 2018-03-19T16:02:55+00:00 March 19th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA, FDA Enforcement News, FDA Enforcement Trends, FDAzilla, Medical Devices|

The FDA Center for Device and Radiological Health (CDRH) has proposed a reorganization that will collapse the Center’s seven offices into four, combining siloes of expertise into a new office that aligns the expertise into teams by product type and technology.  Individuals from the evaluation and compliance groups for specific product types and technologies will now be on one [...]

14 03, 2018

5 Things No One is Talking About Regarding FSMA

By | 2018-03-14T10:02:17+00:00 March 14th, 2018|cGMP Quality Assurance and FDA 483s, FDA Enforcement Trends, Food, FSMA, Supplier Management|

FSMA is a hot topic and the internet is constantly flooded with explanations, tips, and a lot of discussion. But what is missing from the discussion? Here are 5 things that have been overlooked in the headlines and the compliance frenzy: 1. Who has the upper hand? Although FSMA affects food suppliers as a whole, the requirements set some [...]

13 03, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 3/4/18

By | 2018-03-13T12:14:07+00:00 March 13th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, FDAzilla, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers It was a light week on the guidance front particularly from the EMA and the FDA. On the other hand: WHO published two drafts. Health Canada published a final revision to their drug GMPs. And, perhaps more important than all (I admit I’m prejudiced on the topic), is the final version of the [...]

12 03, 2018

[UPDATED] Interval Between Inspection and Warning Letters Decreasing

By | 2018-03-12T12:55:54+00:00 March 12th, 2018|Biopharma / Pharma, FDA Enforcement Trends, FDA Warning Letters, FDAzilla, Form FDA 483|

A blog entry that evaluated FDA enforcement actions in the first half of FY2016 provided data to demonstrate that the interval between GMP drug inspections and warning letters almost doubled since FY2013. The relevant table and graph is provided below. We’ve been watching this trend for the past couple of years, and now we are seeing the reverse—the interval [...]

5 03, 2018

Is AI Coming to FDA Inspection Management?

By | 2018-03-05T17:36:23+00:00 March 5th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement Trends, FDA-Regulated Industry, FDAzilla, Food, Medical Devices|

About 3 months ago, I decided to take a deeper dive into Artificial Intelligence (AI). I've previously written about why and how I'm going to do so, and even coded my first neural network. While AI has been overhyped in the media, it does represent a game-changing technology that will make its way into every industry. As such, how will [...]