cGMP Quality Assurance and FDA 483s

/cGMP Quality Assurance and FDA 483s
1 05, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 4/22/18

By | 2018-05-01T15:45:51+00:00 May 1st, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|

Guidance documents are available from the FDA and EMA this week across a variety of topics.  Lots to read there from both the FDA and EMA. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence Trial today. Enforcement publications were busy this week: 3 drug warning letters from [...]

27 04, 2018

Week of Apr 15th 2018 | FDA Sent These Warning Letters to Pharma Companies

By | 2018-04-27T15:18:49+00:00 April 27th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters|

Maybe back to more normal with 16 warning letters posted this week: The Center for Tobacco Products issued 9 warning letters 3 were issued to manufacturers of finished pharmaceuticals (all are OTC manufacturers located outside the US) 2 were issued to compounding pharmacies So far in CY2018, 14 warning letters out of a total of 33 drug GMP warning [...]

25 04, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 4/15/18

By | 2018-05-08T12:54:13+00:00 April 25th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers FDA published several new guidance, both draft and final, this week: 2 are administrative 2 address quality 1 addresses format for submission of vaccines data Bonus excellent publication: ICH Q&A regarding Q7. It includes just under 60 questions and an appendix that links each Q&A to the section of Q7. TGA published 2 [...]

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 [...]

20 04, 2018

Week of Apr 8th 2018 | FDA Sent These Warning Letters to Pharma Companies

By | 2018-04-20T14:16:50+00:00 April 20th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Warning Letters, FDAzilla|

FDA posted 10 warning letters this week: Several for misbranded drugs 2 in the drug area: 1 for a finished drug manufacturer 1 for a compounding pharmacy Note the FDA ‘requests’ that the firm must respond to. These always provide a roadmap for the type of activities expected of manufacturers who might find themselves with similar challenges. Free learning. [...]

19 04, 2018

A Look Into the Foreign Food Facility Inspection Program

By | 2018-04-19T15:36:57+00:00 April 19th, 2018|cGMP Quality Assurance and FDA 483s, FDAzilla, Food, FSMA|

Due to a recent push by the FDA for more foreign food inspections, it is important that all foreign facilities are up to par. No matter what capacity they contribute in (packing, processing, or holding food) these facilities are subject to inspection by the FDA. It can be difficult to navigate new requirements for foreign facilities under FSMA, but [...]

16 04, 2018

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

By | 2018-04-24T15:40:43+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 [...]