FDA Warning Letters

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 [...]

16 05, 2018

Ready to Make Your Job a Whole Lot Easier?

By | 2018-05-17T11:13:58+00:00 May 16th, 2018|Biopharma / Pharma, CGMP, FDA Inspections, FDA Warning Letters, FDAzilla, Food, Form FDA 483, Medical Devices|

We continuously monitor, collect, sort, tag, and link data from multiple agencies to enable bespoke reports, user-friendly searches, and automated alerts. Equipped with this unrivaled information, you’ll reduce regulatory risk, maximize actionable insights, and minimize research time.

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 [...]

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. [...]

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. [...]