FDA Compliance Features

Alberto Gutierrez's picture
Alberto Gutierrez
During the next few months, manufacturers of certain in vitro diagnostic and radiology products may start to notice they are getting decisions on their premarket notification submissions, aka 510(k...
Michael Causey's picture
Michael Causey
While calling it one of the more “egregious” examples he’s seen or heard about, Fisher Wallace Labs (FWL) CEO Chip Fisher said the Food and Drug Administration’s (FDA) attempt to “force its own...
Banner Medical's picture
Banner Medical
Banner Medical is committed to an ambitious approach to quality assurance, one developed specifically for the evolving, critical needs of the medical device industry. The company believes this...
Michael Causey's picture
Michael Causey
Predicting things on Capitol Hill is never easy, especially as the election campaign “silly season” enters the picture, but it’s beginning to look like medical device companies should expect heavier...
Michael Causey's picture
Michael Causey
Budget-conscious firms that do business in China and elsewhere outside the United States may not like what they find in the Food and Drug Administration’s (FDA) request in the Budget of the...
Julie Gunlock's picture
Julie Gunlock
This year will mark another push for aggressive food regulation at the Food and Drug Administration (FDA). On tap, salt regulations and industrywide regulations dictating which foods can be...
Michael Causey's picture
Michael Causey
It’s actually bigger than a battle over a popular condiment, according to some folks who oppose what they say is the Food and Drug Administration (FDA) overplaying its regulatory hand. We’re not...
ASQ's picture
ASQ
(ASQ: Milwaukee, WI) -- The results of ASQ’s 25th annual Salary Survey show strong average salaries for quality professionals in 2011 and fewer lay-offs as companies continue to see the value of...
Michael Causey's picture
Michael Causey
Under pressure from all sides, the beleaguered Food and Drug Administration (FDA) keeps announcing new reorganization initiatives, name changes, and all sorts of stuff that would be funny if it...
FDA's picture
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...
Patrick Stone's picture
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...
Les Schnoll's picture
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...
Cathy Crawford's picture
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,...
Patrick Stone's picture
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,...
The QA Pharm's picture
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...
FDA's picture
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...
Michael Causey's picture
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...
Dennis Payton's picture
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...
The QA Pharm's picture
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...
ACLASS's picture
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...