Form FDA 483

23 04, 2018

66 New FDA 483s | April 23rd 2018

By | 2018-04-23T15:35:34+00:00 April 23rd, 2018|Biopharma / Pharma, FDA Enforcement Trends, Food, Form FDA 483, Medical Devices, Weekly FDA 483s|

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 to get free weekly content updates designed to make your [...]

12 04, 2018

93 New FDA 483s | April 12th 2018

By | 2018-04-12T16:03:53+00:00 April 12th, 2018|Biopharma / Pharma, FDAzilla, Food, Form FDA 483, Medical Devices, Weekly FDA 483s|

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 to get free weekly content updates designed to make your [...]

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 [...]

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 [...]

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, [...]

27 02, 2018

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

By | 2018-02-27T12:14:29+00:00 February 27th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Warning Letters, FDAzilla, Form FDA 483, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers The FDA issued a collection of guidance the week of February 18th regarding devices, safety, clinical ICH Quality, and administrative items. WHO and TGA each published two new guidance. It was a busy week on the publication front. To see the complete list of laws, regulations, guidance, and concept papers published this week, [...]

22 02, 2018

5 Ways Manufacturing Quality Problems Can Take Down a Company

By | 2018-02-22T17:26:09+00:00 February 22nd, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, FDA-Regulated Industry, Food, Form FDA 483, Medical Devices|

Manufacturing quality issues arise from time to time at pharmaceutical, medical device, and food companies, and if left unchecked, can lead to massive losses. Analyzing FDA inspections and a company's performance provides early insights into any potential issues that may be brewing. Almost all quality-related warning letters start with an inspection and a 483. While some warning letters result [...]

20 11, 2017

Deep Pockets | Does the FDA Get Tougher if the Owner Gets Richer?

By | 2018-02-14T12:13:07+00:00 November 20th, 2017|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement Trends, FDA-Regulated Industry, FDAzilla, Form FDA 483, MOST POPULAR, Pharma - Featured|

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Acquisition of one pharmaceutical firm by another is preceded by due diligence efforts in many functional areas.  Let’s talk about activities in the GMP area.  Firms may not be able to fully rely on past inspections by the FDA to predict the extent of remediation that might be necessary [...]