Another recall in the food industry. We were starting to recover from scandals involving cookie dough (Listeria monocytogenes, Aspen Hills, Inc.), popcorn chicken (‘extraneous materials,’ Tyson Foods) and preserved lemons (undeclared sulphites, Roland Foods, LLC) another case of product contamination hits the headlines. And this time it impacts a very discerning segment of the consumer [Read More…]
Category Archives: FDA
Quick question: When are ‘highly purified phospholipids’ not highly purified phospholipids? Short answer: Perhaps when they are manufactured by Nippon Fine Chemical of Hyogo, Japan. There is much talk within the regulated industries of the critical importance of contamination control, purity, and sterility for pharmaceutical or food-related substances. Anything that eventually becomes part of our [Read More…]
There is little that’s more central to human health than the food that we eat. With each bite, we ingest the vitamins, minerals, fiber, starches, proteins, and fats that we need to fuel, re-build, and maintain our bodies. Each meal provides us with an opportunity to either nourish ourselves or to stress our systems with [Read More…]
Way back in the murky distant mists of time, a trip to your primary care physician might include him listening to your heart, giving you a quick tap on knees to test reflexes, a guffaw about your three martini lunch, and a lungful of second hand smoke from the cigarette burning down in a glass [Read More…]
In a science-fictional universe way ahead of us in the future, there is no industrial complex as we know it today. No sprawling manufacturing campuses or security-patrolled warehouses crammed with shelved inventory. Everything we use on a day-to-day basis is created on demand, at the very moment it is required. All of our homes are [Read More…]
When it comes to cleanroom and controlled-environment news, the stories we read in the press can often be dramatic. Last week, we reviewed a dire situation with ebola where sub-standard gowns, gloves, and glove liners were jeopardizing the lives of medical personnel by allowing bodily fluids to permeate through to the wearer’s skin in a [Read More…]
Although the FDA sometimes has a reputation as a stickler, it’s clear that the Food and Drug Administration often demonstrates a lot of patience, too—except when a company refuses to update their operating procedures to make required fixes to bring their standard operating procedures. Listen: we get it. No one likes to hear phrases like [Read More…]
Ebola. Even that small collection of letters on a page is enough to strike fear into most people. And rightly so. In a recent outbreak of the disease in Liberia, a small West African nation bordered by Sierra Leone and Ivory Coast, ebola killed more than five hundred people. And while that in itself should [Read More…]
Question of the Week: When does owning not one but two slick websites make up for the absence of ethics in aseptic processing? Answer: When it comes to a compounding pharmacy – never! Yet Professional Arts Pharmacy, a compounding pharmacy based in Baltimore, MD, seems to think that it does. With a confidence-inspiring main website [Read More…]
Imagine the scenario: after experiencing weeks of sudden and unexplained pain in your stomach, your doctor – suspecting ulcers – refers you to the hospital for tests. Or perhaps you rush your toddler to the ER after he swallowed part of his favorite action figure. In either of these cases, your immediate future involves getting [Read More…]