FDA Enforcement Trends

18 05, 2018

Week of May 6th 2018 | FDA Sent These Warning Letters to Pharma Companies

By | 2018-05-18T13:12:09+00:00 May 18th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters|

FDA posted 12 new warning letters this week. Among the ones we cover one to a finished pharmaceutical firm. Want to see the complete list of enforcement documents — including recalls, alerts, and import alerts from this week? Start your FREE trial of the GMP Regulatory Newsletter today. Goran Pharma Private Limited (Gujarat, India) received a warning letter dated April [...]

11 05, 2018

Week of Apr 29th 2018 | FDA Sent These Warning Letters to Pharma Companies

By | 2018-05-11T14:58:07+00:00 May 11th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters|

The FDA and Federal Trade Commission issued 13 warning letters this week to manufacturers and retailers selling e-liquids used in e-cigarettes. One of the objections was that the packaging resembles kid-friendly food products; others included selling these items to minors. FDA published 1 warning letter to a compounding pharmacy. This is a slow enforcement week for drugs and devices. [...]

4 05, 2018

Week of Apr 22nd 2018 | FDA Sent These Warning Letters to Pharma Companies

By | 2018-05-04T12:55:48+00:00 May 4th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters|

FDA posted 6 new warning letters this week: The Center for Tobacco issued 3 of them 1 warning letter went to an API manufacturer 2 warning letters were issued to finished pharmaceuticals manufacturers of OTC products DRUGS: Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd (Yunnan, China) received a warning letter on April 19th 2018 based on the outcome of [...]

2 05, 2018

[INFOGRAPHIC] The FDA, Warning Letters, and What to Expect in 2018

By | 2018-05-03T13:49:02+00:00 May 2nd, 2018|Biopharma / Pharma, CGMP, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, Medical Devices|

New synthesized data shows that total warning letters continued to climb in 2017. [NEVER MISS A WARNING LETTER: Start your 30 day free trial of the GMP Regulatory Intelligence Newsletter.] Outside the US Of course, this is part of the on-going trend of increased international inspection activity as the FDA "catches up" with the reality that 80% of all [...]

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 [...]

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. [...]

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 [...]