All Features
FDA
The Food and Drug Administration’s (FDA) international program has logged nearly 75,000 hits to its web pages on the new food safety law, as foreign companies that export food to the United States scramble to learn how the law affects them.
“A lot of our foreign offices are being deluged with…
Patrick Stone
What products will be affected by the Food and Drug Administration’s (FDA) quality by design (QbD) stipulation, as outlined in its report, “Pharmaceutical Quality for the 21st Century: A Risk-Based Approach”?
It will apply to new marketing authorization applications, new drug applications, Type…
Les Schnoll
According to recent data from the Centers for Disease Control and Prevention, every year about 48 million people get sick, 128,000 are hospitalized, and 3,000 die from food-borne diseases. Hardly a day goes by where there isn’t another recall of food contaminated with a variety of microorganisms…
Cathy Crawford
As of July 3, 2011, the Food and Drug Administration (FDA) has increased authority to use administrative detention as an enforcement tool. For this reason, companies that manufacture, prepare, pack, or hold food should ensure strong record-keeping practices.
Under the current criteria of the…
Patrick Stone
I don’t know about you, but I sleep easier now knowing that our Food and Drug Administration (FDA) has declared war on unpasteurized milk in the United States [Editors note: also see Fox News, NaturalNews.com]. It’s not enough that the U.S. government is fighting the war on terror (an oxymoron)…
The QA Pharm
Responses to the Food and Drug Administration’s (FDA) Warning Letters and the FD483—a written notice of deficiencies found during inspections—are usually full of commitments. They involve what will be done to correct compliance problems, and when it will be done. The FDA has even started to ask…
FDA
As headlines from Europe implicate tainted vegetable sprouts in more than 4,000 illnesses and dozens of deaths, American consumers may wonder, “Could that happen here?”
The United States has had its own headline-grabbing outbreaks from contaminated vegetables—such as lettuce in 2010, peppers in…
Michael Causey
Well, this is getting interesting. For the past several months, we’ve had relatively partisan folks on each side of the medical device industry vs. the Food and Drug Administration (FDA) debate saying either the 510(k) premarket notification process wasn’t doing so badly (the FDA), or that it was…
Dennis Payton
With the explosive growth in imported goods to the United States, what is the Food and Drug Administration (FDA) doing toward maintaining a level of service inspection that ensures the best protection of the public health? One option is to partner with the countries exporting the supplies. Perhaps…
The QA Pharm
Just when you think that the Food and Drug Administration (FDA) has to stick to the script by quoting chapter and verse of current Good Manufacturing Practices (CGMPs), it gets very progressive and offers straight talk about corporate commitment and leadership.
I have reported before that the FDA…
ACLASS
Keith Greenaway, vice president of ACLASS, a brand of ANSI-ASQ National Accreditation
Board that provides accreditation, gave a brief talk titled “Focus on Inspections and Compliance” at the FDA Food Safety Modernization Act public meeting held on June 6, 2011. His prepared remarks follow:
The…
Kimberly Egan
I don’t know how I missed this gem, but on March 24, 2011, the Food and Drug Administration (FDA) sent a Warning Letter to Jonathan’s Sprouts Inc. informing the company that it was (among other things) marketing its organic mung bean, alfalfa, and broccoli sprouts as drugs. The FDA said it has…
Mike Richman
Last month I wrote an article entitled “Being Comfortable in a World of Never-Ending Change.” Editor in Chief Dirk Dusharme and I also covered this story on the April 29th edition of Quality Digest Live (QDL). QDL, by the way, is our live video show wrap-up of the week’s top industry news and…
The QA Pharm
Can you imagine the stream of firms that venture into their respective FDA district offices to give presentations on their warning letter response and to offer their assurance that they truly “get it?” You can be sure these firms had several dry runs and dress rehearsals to hone their material…
Cor Groenveld
How safe is our food? It is a question asked all over the world on a daily basis as food-scare stories fill the media and governments act to calm consumer fears. There is a real and tangible concern among the public; an IBM consumer confidence survey in 2009 found that 80 percent of those…
Mike Richman
Welcome to Quality Digest Daily 2.0! This new format represents a significant re-imaging of our flagship brand (the industry’s only daily newsletter), which we first launched nearly two years ago. I hope you notice that we’ve added more video content to the newsletter as well as greater editorial…
Quality Transformation With David Schwinn
“Under-promise, over-deliver” is a phrase taught to me many years ago by my friend and colleague, PQ Systems’ owner Michael J. Cleary. It may have always been true. It may always be true. It is certainly true today.
I am in the middle of a sabbatical that requires me to buy and learn to use new…
The QA Pharm
A March 30, 2011, Food and Drug Administration (FDA) Warning Letter to Ningbo Smart Pharmaceutical Co. revealed that it had reported conformance to specifications on certificates of analysis, when in fact no testing was done—among other issues.
The FDA rather understatedly informed Ningbo Smart, “…
Lisa Lupo
Companies aren’t perfect, and neither are the people who work for them. Since this is a fact rather than a judgment, it’s reasonable to expect errors in manufacturing and process management. When an audited company continues to show a flawless record for, say, a food-safety audit, chances are it…
Danita Johnson Hughes Ph.D.
Read this. It won’t be a waste of time.
Time gets lost. People kill time. Time flies. It gets wasted. Time weighs heavy on our hands. We spend time. Time passes. It drags on or it hurries by. Those behind bars are said to be doing time. Sometimes, we have no time left; we’re out of time.…
TraceGains
Under the Food Safety Modernization Act (FSMA), food manufacturers and processors who import food ingredients and raw materials will be required to implement a Foreign Supplier Verification Program, essentially mandating that foreign suppliers undergo the same rigor and scrutiny as domestic ones.…
TraceGains
Under the Food Safety Modernization Act (FSMA), food manufacturers and processors who import food ingredients and raw materials will be required to implement a Foreign Supplier Verification Program, essentially mandating that foreign suppliers undergo the same rigor and scrutiny as domestic ones.…
The QA Pharm
By the time a consent decree comes along—which happens when a firm repeatedly violates current good manufacturing practice (cGMP) requirements and the Food and Drug Administration (FDA) forces it, through legal channels, to make specific changes—it’s no longer a discussion about responses to…
The QA Pharm
By the time a consent decree comes along—which happens when a firm repeatedly violates current good manufacturing practice (cGMP) requirements and the Food and Drug Administration (FDA) forces it, through legal channels, to make specific changes—it’s no longer a discussion about responses to…
Bruce McDuffee
If you’re in the business of manufacturing drugs, medical devices, nutraceuticals, or manufacturing or importing any product in the United States that falls under current Good Manufacturing Processes (cGMP) regulations, your facility will be inspected by the U.S. Food and Drug Administration (…
