Medical Devices

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 [...]

16 04, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 4/8/18

By | 2018-04-20T09:26:23+00:00 April 16th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters, FDAzilla, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers A bit of a busier week than last week for guidance: The FDA published 6 documents. Nothing from EMA in the areas we follow. WHO, CDSCO, Health Canada, TGA, and HPRA also published guidance. Non-guidance publications from the usual sources MHRA, EMA, FDA. Also of interest is 1 each from TGA and PMDA. [...]

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 [...]

10 04, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 4/1/18

By | 2018-04-10T13:36:13+00:00 April 10th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters, FDAzilla, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers It’s been a slow week all around, perhaps spring breaks and the holidays? Among the non-guidance publications, CFDA published an update on their 2017 Review Metrics. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence Trial today. Enforcement A very slow enforcement [...]

30 03, 2018

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

By | 2018-04-04T16:46:03+00:00 March 30th, 2018|Biopharma / Pharma, FDA Enforcement Trends, FDA Warning Letters, FDAzilla, Medical Devices|

FDA posted 7 warning letters this week. Among those we cover: 1 to an API firm 2 to finish pharmaceutical manufacturers 1 to a device manufacturer We cover these below. The warning letters issued to drug firms all have significant requirements associated with them that firms are to address. We include these requirements because they provide a roadmap of [...]

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 [...]

23 03, 2018

Week of Mar 11th 2018 | FDA Sent These Warning Letters to Device & Pharma Companies

By | 2018-03-23T14:22:21+00:00 March 23rd, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Warning Letters, FDAzilla, Medical Devices|

FDA posted 11 warning letters this week: 3 were issued to duodenoscope manufacturers (we identified those last week) 2 warning letters went to device firms 1 to a contract testing laboratory in France 1 to a compounding pharmacy DRUGS/CONTRACT TEST LABORATORY: Quali-Controls & Quali-Controle C.E. BAC (Meru, France) received a warning letter on March 5th 2018 based on the [...]

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. [...]