GMP News: Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters

Updated August 4, 2024

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Warning Letters - FDA.gov

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Read the full article: GMP News: Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters:

"The analysis of the warning letters issued in the last fiscal year shows no surprise at a first glance: as in recent years the FDA detected an insufficient investigation of unexplained discrepancies and deviations from defined standards and specifications in their inspections. The corresponding paragraph 21 CFR 211.192 

that the drug maker clarifies the reason for the deviation, takes corrective actions and also creates a complete documentation. In the last 5-year period on average annually about 22 companies received a warning letter listing this GMP deficiency. This fact shows that many quality assurance departments' understanding of deviations handling, failure investigations and corrective actions is frequently fragmentary."

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Pharma Cargo Theft Takes New Spike - FiercePharma Mfg

Pharma cargo theft takes new spike - FiercePharma Manufacturing:

"the trend has turned up again. The logistics and security company reported that in 2013, full-truckload pharmaceutical thefts jumped by 50% to 33 from 22, with the average loss up 14.15% to $261,819. Total pharma thefts, including last-mile cargo theft, spiked to 83, with an average loss of $180,346 in 2013. That was up from just 36, with an average loss of $153,697, in 2012. Last-mile thefts usually involve street criminals who rip off pharmacy delivery vans."

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FDA Focusing On Food & Drug Manufacturing GMP Compliance

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Updated December 9, 2021

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Current Good Manufacturing Practice (CGMP) Regulations - FDA.gov

Compliance & Enforcement (Food) - FDA.gov

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FDA is focusing on cGMP compliance by food and drug manufacturers.

FDA investigative chief eyes manufacturing practices:

"John Roth, director of the FDA's Office of Criminal Investigations, said officials are seeking to ensure that companies are appropriately balancing their profit motives with the need to manufacture food and drugs responsibly.

The meningitis outbreak and other recent cases have spurred the agency to take a closer look at this balance, Roth told lawyers at an American Bar Association-sponsored conference in Las Vegas focused on white-collar crime.

"We wonder exactly if this is a systemic problem, if it requires a broader response by the FDA or is it an anomaly," Roth said in a panel discussion Friday. "We're going to be taking a look at that and hopefully we'll launch in a thoughtful way.""

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On the FDA website - FD&C Act Chapter III: Prohibited Acts and Penalties

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2012 Crystal Ball Predicts a More Aggressive FDA

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Updated February 2, 2021

Links in the original post broke.

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2012 Crystal Ball Predicts a More Aggressive FDA:

"According to the FDA website, 2012 will be a year of global regulatory operation and enforcement with emphasis on medical devices, drugs, and food products. "

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The article references:

The FDA Pathway to Global Product Safety and Quality

It's hard to believe 2011 is nearly over, and 2012 is around the corner.  Here's to future trends!

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2011 - Global Pharma To Grow 5-7 Percent

2011, here we come.

IMS Health Forecasts Global Pharmaceutical Market Growth of 5-7 Percent in 2011, Reaching $880 Billion

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2011 Pharma Trends

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Updated March 12, 2022

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You might also like:  Introducing the Pharma 2020 series - PWC.com

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It's that time of year again.

Brandon says, in Global Pharmaceutical Market Expected to Rebound in 2011:

• the global pharmaceutical market will experience 5% to 7% growth in the coming year, compared with only 4% to 5% in 2010.

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More Pharma 2010 Trends

... and even more pharma trend predictions for 2010.

Tracy Staton reports in What's the outsourcing outlook for 2010?, what we can expect in 2010 from an outsourcing perspective.

In summmary, expect:

• Outsourcing won't let up in 2010
• Outsourcing to heat-up in sales, IT, and CROs 

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Pharma Mergers - 2009 review - 2010 predictions

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Continuing the thread of the pharma year in review, and what 2010 might look like. Here's a Motley Fool look at 2009 and 2010 from the perspective of pharmaceutical mergers and acquisitions, 2009: The Year Pharma Learned to Love Itself. In a nutshell:

1. 2009 ushered in a number of consolidations
2. Consolidations might not work well or scale well due to the challenges of integration
3. The author, Brian Orelli predicts for 2010, "While anything is possible, I wouldn't expect much more consolidation of major drugmakers."

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Cramer - Top 4 Healthcare Predictions for 2010

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... rather, that's Cliff Cramer. In looking for 2010 trends, and predictions, I stumbled across his predictions, Top 4 Healthcare Predictions for 2010. It's the start of an interesting and provocative discussion of his 4 predictions (which I've truncated):

1. Multi-national pharmaceutical and medical technology companies will increase their investments in emerging markets.
2. Information technology will make greater strides in a healthcare industry.
3. Healthcare reform will continue across developed and developing markets.
4. Consolidation will be a major theme in 2010.

I recommend you go to his post, and jump into the discussion. On some gut level, I'm hoping the predictions ring true as my retirement investments will benefit.

Previous Posts: Biotechnology Trends 2010 - Free Report 

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Biotechnology Trends 2010 - Free Report

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Here's the next installment of my hunt for 2010 trends, forecasts, and predictions. Pharma-Reports.com just announced the availability of its executive report, Biotechnology Trends 2010 (free). I've provided the link to the request form. The report examines the most significant trends in biotechnology and their impact on rising health care costs, the aging population, and an overall rise in the incidence of disease. The report also discusses scientific advancements in proteomics and biomarkers, molecular manufacturing, and the development of smart materials.

Previous Posts: Looking Ahead to Pharma 2010 - Through the IBM innovation lens GMP Training - The end is near - I mean 2009! IMS Predicts Pharma Growth in 2010 CDC - Brand New 2010 Yellow Book for Travelers - free - online 

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Looking Ahead to Pharma 2010 - Through the IBM innovation lens

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2010 is approaching fast. This is the time of year I start watching out for crystal ball predictions of what's in store for us. For example, check out IBM's vision for 2010, Pharma 2010: The Threshold of Innovation (pdf). 

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IMS Predicts Pharma Growth in 2010

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I can hardly believe 2009 is almost over. It's time to start looking ahead to 2010 trends. I caught this article on Pharmaceutical-ManufacturingNews.com, IMS Forecasts Global Pharmaceutical Market Growth Of 4 - 6% In 2010. IMS Health forecasts 4-6% growth in 2010, and 4-7% through 2013. 

Previous Posts: 2009 Pharmaceutical Trends 

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Top Trends For The Medical Equipment Market

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Updated February 27, 2026

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GVR Report coverU.S. Durable Medical Equipment Market Size, Share & Trends Report

U.S. Durable Medical Equipment Market (2026 - 2033): 

https://www.grandviewresearch.com/industry-analysis/us-durable-medical-equipment-dme-market

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Another year year has gone by, and it was a tough one at that. Wishing you the best this coming 2009. As a preview of what's to come, read this excellent analysis by the folks at Reports-Research.com, "Top 10 Medical Equipment Market Trends For 2009." If you don't have time to read this detailed post, here are the high points . . .

1. Obama Plans To Bring Stellar Growth For Healthcare Information Technology
2. Home Healthcare Equipment Market Is Poised For A Big Return In 2009 Owing To Cost Containment Efforts By Both Providers And Purchasers
3. Emerging Medical Equipment Markets Will Continue To Grow In 2009, Assisted By The Ongoing Trend Towards Medical Tourism And Helping To Offset Any Negative Impact Felt By The General Economic Downturn
4. Major Medical Equipment Manufacturers To Remain Stable In Spite Of Mounting Financial Crisis
5. Direct To Consumer Advertising Of Medical Devices To Continue To Increase In Prominence In 2009
6. Healthcare Information Technology Spend To Gain Significant Attention In 2009 And Beyond From Both Developed And Emerging Economies
7. Drug Eluting Stents On A Comeback Trail In The US Market
8. In 2009Young Adults And Middle Aged Patients To Drive The US Market For Hip Resurfacing For Next Five Years
9. Cash Rich And Innovative Companies To Benefit In The Current Economic Scenario
10. Products Related To Women’s Health, Minimally Invasive Surgery And Home Healthcare Are Set To Garner Special Attention In 2009
11. High Volume And Low Value Of Deals Will Be A Norm In The Medical Equipment Mergers And Acquisitions Landscape In 2009

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Get In Shape - Trying one of these 20 fitness trends?

Updated June 4, 2025

The original link broke.

You can still read about the same topic on the ACSM website:

https://acsm.org/education-resources/trending-topics-resources/acsm-fitness-trends/

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The holidays are almost over. Are you going to try and follow one of these top fitness trends in 2009, reported by MedicineNet, "American College of Sports Medicine Survey Predicts Next Year's Fitness Trends." Here's the what the professionals think will be hot in the coming year . . .

1. Educated and experienced fitness professionals
2. Children and obesity
3. Personal training
4. Strength training
5. Core training
6. Special fitness programs for older adults
7. Pilates
8. Stability ball
9. Sport-specific training
10. Balance training
11. Functional fitness
12. Comprehensive health programming at work
13. Wellness coaching
14. Worker incentive programs
15. Outcome measurements
16. Spinning (indoor cycling)
17. Physician referrals
18. Exercise and weight loss
19. Group personal training
20. Reaching new markets

Do you have a workout plan for 2009?

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