Medical Devices

22 03, 2018

46 New FDA 483s | March 22nd 2018

By | 2018-03-22T12:59:11+00:00 March 22nd, 2018|Biopharma / Pharma, FDAzilla, Food, Form FDA 483, Medical Devices, Weekly FDA 483s|

This past 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. [...]

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 [...]

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 [...]

7 03, 2018

75 New FDA 483s | March 7th 2018

By | 2018-03-07T15:52:28+00:00 March 7th, 2018|Biopharma / Pharma, FDAzilla, Food, Form FDA 483, Medical Devices, Weekly FDA 483s|

This past 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. 483 3M Company Milford  Nov 2015 483 Accupack Midwest Cincinnati  Oct 2012 483 Advanced Interventional Pain Ctr IRB Lafayette  Oct 2013 483 AdvancePierre Foods Amherst  Mar 2011 483 Agnes E. Ubani, [...]

6 03, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 2/25/18

By | 2018-03-06T12:39:19+00:00 March 6th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Inspections, FDAzilla, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers FDA published four guidance documents this week: Two that address implementation of drug track and trace activities Two that focus more on medical and safety The EMA published one item focused on inclusion of excipients in labeling. The non-guidance set of publications includes items from the EMA, FDA, MHRA, CDSCO, and TGA. Also [...]

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 [...]

2 03, 2018

Week of Feb 18th 2018 | FDA Sent These Warning Letters to Device & Pharma Companies

By | 2018-03-06T12:40:26+00:00 March 2nd, 2018|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Warning Letters, FDAzilla, Medical Devices|

A collection of warning letters were issued from the Center for Tobacco Products this week. In FY2017, the center issued 97% of all warning letters issued by the FDA. Also, the FDA issued one warning letter to a finished drug manufacturer and one to a device manufacturer. Both warning letters were issued to sites outside the US. We cover [...]

28 02, 2018

43 New FDA 483s | February 28th 2018

By | 2018-03-06T12:41:28+00:00 February 28th, 2018|Biopharma / Pharma, FDAzilla, Food, Medical Devices, Weekly FDA 483s|

This past 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. 483 American Red Cross Blood Services Farmington  Jun 2010 483 Amneal Pharmaceuticals Paterson  Nov 2008 483 Amneal Pharmaceuticals Paterson  Nov 2013 483 Amneal Pharmaceuticals Paterson  Oct 2017 483 AMO Puerto Rico [...]