FDA-Regulated Industry

/FDA-Regulated Industry
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.

15 05, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 5/6/18

By | 2018-05-15T14:40:04+00:00 May 15th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers A collection of both draft and final guidance: The FDA and EMA published this week Others also issued guidance including WHO, HPRA, Health Canada, TGA, and CDSCO.  Much to read! Also, the non-guidance publications continue: MHRA, EMA, and FDA published Among this later collection are the MHRA GCP Inspection Metrics Changes in the [...]

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. [...]

8 05, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 4/29/18

By | 2018-05-08T13:19:00+00:00 May 8th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers Guidance documents were in modest supply this week: 4 from FDA 4 from EMA 2 from Health Canada 2 items from Pakistan FDA also withdrew 1 final rule due to “significant adverse comments” received during the comment period ending April 11th 2018. This one is important. To see the complete list of laws, [...]

7 05, 2018

114 New FDA 483s | May 7th 2018

By | 2018-05-07T13:46:02+00:00 May 7th, 2018|Biopharma / Pharma, 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 [...]

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 [...]

3 05, 2018

The Secret Life of (b)s

By | 2018-05-03T16:09:42+00:00 May 3rd, 2018|Biopharma / Pharma, CGMP, FDA Inspections, Food, Form FDA 483, Medical Devices|

I recently discovered a gap in my education. Like you, I’ve seen my share of redacted 483s and EIRs. Those redactions are marked with a “(b)” followed by a number in parentheses. I’m normally a curious person, but it never occurred to me that those letters and numbers had a meaning. I had an aha (and color me red) moment [...]

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 [...]