Dark Brown Colored Liquid
(Verbatim • Factory Food)
Or, How Much is that Flavor Enhancer in the Window,
The One With the Waggily Salmonella Infestation?
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
Dates of Inspection: 02/12/2010 – 03/04/2010
TO: Kanaiyalal N. Patel, President
Basic Food Flavors, Inc.
North Las Vegas, NVDURING AN INSPECTION OF YOUR FIRM WE OBSERVED:
OBSERVATION 1
Failure to manufacture, package, and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.Specifically, your existing manufacturing process inside building 3950 Craig Road was not designed with the necessary steps to control microbial contamination as evidenced by the following:
(A) XXXXXX samples from one remaining finished product lot of your HVP XXXXXX were analyzed and found positive for Salmonella by your private laboratory. This was documented by Certificate of Analysis XXXXXX dated 2/19/2010.
(B) Environmental samples collected from building 3950 Craig Road found Salmonella on non-food contact surfaces near some food processing equipments throughout this facility. These findings were documented on the following private laboratory certificates of analysis provided to the FDA…
After receiving the first private laboratory analytical results (Certificate of Analysis XXXXXX dated 1/21/2010) indicating the presence of Salmonella in your facility, you continued to distribute HVP paste and powder products until 2/15/2010. Furthermore, from 1/21/2010 to 2/20/2010, you continued to manufacture HVP paste and powder products under the same processing conditions that did not minimize microbial contamination.
OBSERVATION 2
Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food-contact surfaces.Specifically, on 2/14/2010, we observed disassembled equipment with accumulation of food debris and accumulation of dark brown colored liquid. According to your firm’s Quality Assurance/Food Technologist these surfaces have been cleaned and ready to be assembled for production. The specific food contact surfaces observed are described as follows:
1. Light brown residue was observed on the ledge close to the hinge of the east door of Large Paste Mixer.
2. Dark brown liquid was observed inside the Still XXXXXX outlet to the paste mixers. Still XXXXXX is XXXXXX holding tanks that feed in-process material into the paste mixers.
3. Brown residue and dark brown liquid were observed on the stainless steel filter screen and inside its housing. XXXXXX
4. Dark brown liquid residue was observed inside the XXXXXX conveying pipe located after the hopper outlet of Belt Dryer XXXXXX. We were informed by your firm’s Quality Assurance/Food Technologist that during production, this pipe transports XXXXXX.
5. Brown residue was observed on the inside surface of exit end of the white PVC pipe located between Mixers XXXXXX and XXXXXX inside the Grinding/Packing Room. This PVC pipe is used for diverting overflow product that can be eventually incorporated into a finished product. …OBSERVATION 3
The plant is not constructed in such a manner as to allow floors to be adequately cleaned and kept clean and kept in good repair. …Moreover, we observed floor fractures and crevices along the trench drains in the Evaporator/Paste Mixers/Belt Dryers areas. Standing water was also observed in the floor areas nearby these trench drains. We observed production employee and forklift traffic in these areas and into the Grinding/Packing Room where finished powdered products are packed.
Your firm’s environmental sample results were positive for Salmonella from or near these floor areas.
OBSERVATION 4
Plumbing is not adequately installed and maintained to provide adequate floor drainage.Specifically, during our inspection of the Evaporator/Paste Mixers/Belt Dryers areas, we observed standing, grey/black liquid in the square drain at the north end of the building, while you were manufacturing hydrolyzed vegetable protein (HVP) paste into powder products. Further, we sensed an odor in the vicinity of this drain, which collects discharge water from the east and west trench drains.
Your firm’s environmental sample results were positive for Salmonella from or near these drain areas. …
Basic Foods has, until recently, refused to respond to media inquiries about the recall of products containing its HVP flavor enhancer, which now numbers 160. But finally the company relented, telling Food Navigator-USA:
“While it is unclear whether FDA is suggesting in the Form 483 that Basic Foods knowingly shipped adulterated product, the language used by the agency and reported by the press has created that implication. We, therefore, consider it important to clarify that Basic Foods has not knowingly shipped into commerce any product the Company believed had the potential to contain Salmonella.”
So why didn’t the company just say so a few days ago when the FDA released its inspection report?
“Quite honestly, we didn’t bother answering the press because we just wanted it to go away,” Basic Foods Sales and Marketing Manager David Wood told Food Navigator. “…It’s working. It’s beginning to die down.”
The reader is invited to reach the reader’s own conclusions.
→ B.Dunn, Mar 21, 2010, 07 30 am
State of the Union, Cliff Notes Version
(Verbatim • Politics)
Jon Stewart provides the quote of both the moment and the year, within a painfully humorous video clip worth watching if you can stomach politics without causing your ulcer to flair up and also have 10 minutes to spare (or at least slide the video bar over and watch the last 5, ‘cause that’s the best part):
And that, kids, is coincidentally also why the captains of the insurance and banking industries will continue to own three or four mansions apiece for the next three years and don’t really give a crap about whatever kind of mortgage or health insurance payments they may have to make.
→ B.Dunn, Jan 20, 2010, 07 32 am
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Medicine That Makes You Sick
(Be Afraid • Verbatim)
The bottom line today is that Johnson & Johnson and officials with their McNeil Healthcare pill factory in Puerto Rico are more interested in perpetual maximum sales than in the effects their pills may have on the people who buy them.
The bottom line is that some people have been buying those products with the hope that they would become more healthy as a result. Instead, they wound up getting sicker.
The bottom line is that if you have extra-strength Tylenol, chewable Children’s Motrin or their caplets, “meltaway” children’s Tylenol or Benadryl tablets, or Rolaids or St. Joseph chewable aspirin or “Simply Sleep” products, they might contain a wood-treatment chemical called Tribromoanisole, or something else entirely, that has been making people sick. Click here to see if you have some of the medicine that will make you or your children sicker instead of better.
The bottom line is that Johnson & Johnson knew its pills were probably contaminated since at least September 2008, but company officials took minimalistic action for almost a year and a half and apparently only issued a recent and expanding recall after pressure from the Food & Drug Administration, including the likes of a threatening letter, reproduced in part below:
Mr. Peter Luther, President, NA OTC
McNeil Consumer Healthcare
7050 Camp Hill Road Mb # 204
Fort Washington, PA 19034Dear Mr. Luther:
This is regarding an inspection of your pharmaceutical manufacturing facility, McNeil Healthcare LLC, located at Road 183, Km. 19.8, Sector Montones, Las Piedras, Puerto Rico 00771, conducted by investigator J. Lopez and chemist R. Gonzalez and concluded on January 8, 2010. The inspection identified significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations…
Specific violations observed during the inspection include, but are not limited, to:
1. Failure to thoroughly investigate any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed. In addition, you failed to extend the investigation to other batches of the same product and other products that might have been associated with the discrepancy as required by 21 C.F.R. § 211.192.
Your company has determined that the “uncharacteristic odor” complaints, some of which were associated with adverse event reports (gastrointestinal distress), for several of your OTC drug products are due to 2,4,6 Tribromoanisole (TBA) contamination in the product and/or bottles. TBA, which has a musty, mildew-type odor, is a known degradant of 2,4,6, Tribromophenol (TBP). TBP is a pesticide and flame retardant used to treat wooden pallets for transporting packaging materials and finished product. TBA is organoleptically detectable at parts per trillion. You are currently attributing the cause of the uncharacteristic odor to be contamination of the drug product containers from TBP treated wooden pallets. You have concluded that TBP from the wooden pallets degraded into TBA, which contaminated product containers and the finished product in those containers.
The contamination, first noted in 2008, occurred again in 2009, leading to recalls of several lots of Tylenol Arthritis Relief caplets, 100 count bottles, 650 mg. More recalls are being conducted including multiple other OTC drug products.
We are aware of the complaint information available to your company, the sequence of events, and the extent of your firm’s follow up measures during this period. We have concluded that your company did not conduct a timely, comprehensive investigation.
Your initial investigation into the root cause of the odor was unjustifiably delayed and terminated prematurely. Numerous complaints were received over a four month period in 2008 before they were considered a trend and before actions were initiated to determine the root cause. When microbiological testing in August 2008 did not support an initial speculation that microbial contamination was the root cause of the odor, the investigation was closed. No other possible root causes were pursued. Your firm lacked adequate justification for this decision.
Complaints of uncharacteristic odor were reported again in April 2009. Approximately 112 similar complaints were received by August 3, 2009. Although your firm had test results indicative of contamination with TBA as the source of the off odor on the complaint samples since September 2009, these results were not shared with FDA until after the initiation of the inspection and following several requests for this information made by the district office.
In October 2009, you concluded that the most probable root cause of the odor in the Tylenol Arthritis Relief caplets was the exposure of drug product bottles to wood pallets chemically treated with TBP. You did not expand the scope of the investigation to other lots and products potentially affected by this deviation. This would include, for example, products packaged in bottles from the same supplier that used the same type of wooden pallets, and other products manufactured by your facility for which odor complaints were received…
The Agency is concerned about the response of Johnson & Johnson (J&J) to this matter. It appears that when J&J became aware of FDA’s concerns about the thoroughness and timeliness of McNeil’s investigation, whether all potentially affected products had been identified, and whether the recall was adequate in scope, J&J did not take appropriate actions to resolve these issues. Corporate management has the responsibility to ensure the quality, safety, and integrity of its products. Neither upper management at J&J nor at McNeil Consumer Healthcare assured timely investigation and resolution of the issues.
The bottom line is that Johnson & Johnson and numerous other corporations engaged in the production of “food” and “medicine” are essentially laughing at what passes for government safety regulations and will happily continue selling us tainted products until the point comes where potential or actual lawsuits cost more than profit from continued sale of the aforementioned crap.
The FDA obviously needs the authority to immediately shut down manufacturers who have demonstrated a willingness to poison or sicken people. It is my opinion that professional corporate bribers acting in concert with Congress have helped make sure this doesn’t happen.
In case you haven’t figured it out by now, the bottom line is that there is no reason to ever wait for the government to do the right thing. But you can take one small step in assuring your family’s safety from adulterated drugs. Just stop buying all products made by Johnson & Johnson and its divisions.
→ B.Dunn, Jan 17, 2010, 10 02 am
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They Shoot Editors, Don't They?
(Media • Verbatim)
But at the Dallas Morning News, they torture them first.
Yesterday the newspaper that once provided watchdog journalism across the state of Texas began turning supervision of what’s left of a decimated newsroom over to the advertising department.
Below, the Morning News editor outlines Reason #43, Why I Am Ecstatic I No Longer Work As A Newspaper Journalist:
From: Mong, Bob
Sent: Wednesday, December 02, 2009 4:41 PM
To: Everyone…
Subject: Memo from Bob Mong and Cyndy Carr…Colleagues:
Today we are launching a new business segment structure as the next step toward becoming the most comprehensive and trusted partner for local businesses in attracting and retaining customers and continuing to generate important, relevant content for our consumers.
To better align with our clients’ needs, we will be organized around eleven business and content segments with similar marketing and consumer profiles including: sports, health/education, entertainment, travel/luxury, automotive, real estate, communications, preprints/grocery, recruitment, retail/finance, and SMB/Interactive.
Each segment will be led by a General Manager (GM), a newly-defined role, each reporting to Cyndy Carr, charged with analyzing and growing the business by developing solutions that meet consumer needs and maximize results for our clients. Their responsibilities will include sales and business development. They will also be working closely with news leadership in product and content development.
In the Sports and Entertainment segments, the senior news editors will report directly to the GM while retaining a strong reporting relationship to the editor and managing editor. These collaborations will bring new products that consumers want to the market more rapidly. We are proceeding knowing and trusting each other’s distinct roles and responsibilities in the same way our News leadership and our Publisher have worked collaboratively for years.
This business/news integration is a progressive step and is strongly supported by the news leaders of both the Sports and Entertainment segments:
“As a segment, we have a lot of advantages usually associated with a start-up,” said Bob Yates, deputy managing editor and Executive Sports Editor. “We should be able to move much more quickly to take advantage of opportunities. That comes from having greater autonomy that gives us the freedom to develop both advertising and content solutions.”
“As a journalist who has participated in many new product launches, I’m excited about the idea of working with a business partner on an arts and entertainment segment,” added Lisa Kresl, deputy managing editor for Lifestyles. “Our high quality, credible content will reach new audiences in a variety of formats.”
The new segment leadership team is comprised of a very talented and accomplished group of business professionals:
Entertainment and Travel/Luxury Segments: Tracy Martin Taylor is the GM for the Entertainment and Travel/Luxury segments. As part of the new GM role, Tracy will be responsible for overseeing content. Tracy will continue her role as Quick Publisher and assume the role of FD Luxe Publisher. Prior to joining The News in July, she was in sales management at Clear Channel Radio and marketing at Wherehouse Music.
Sports and Health/Education Segments: Rich Alfano is the newest member of our management team. Rich worked for Times Mirror Magazines and served as President of Yachting, Saltwater Sportsman and Golf Magazine. He has most recently served as Senior Vice President/General Manager and SVP/Strategic Marketing for Practitioner’s Publishing Co./Thomson Reuters. His professional success and experience in several industries makes him ideally suited to lead two of our high-growth segments. …
As The Dallas Morning News approaches its 125th anniversary in 2010, our business stands at a critical crossroads. Our success depends on employing bold strategies to evolve our organization: our home delivery pricing strategy (on which Jim and John updated us on Monday), our continued dedication and investment in important and relevant journalism that makes a difference in our community and the ongoing development of our product portfolio have all played a role in changing our approach to how we do business.
This restructure and strategic integration with news, along with the many other strategies we’ve put into place this year to better serve our clients and consumers, position us for significant growth and stability as we head into the new year.
Cyndy Carr Bob Mong
SVP/Sales Editor
Uh-huh. The quotes above totally convince me that the Morning News sports and entertainment editors have been waiting their whole careers for the opportunity to have their every move second-guessed by a radio advertising sales manager.
Note that “clients’ needs” and “readers’ needs” are not even close to the same thing. As usual among big-newspaper executives, the perceived importance of readers’ needs is approximately that of a rat’s ass.
Boy, daily newsroom budget meetings probably will be a real blast when the new ad new bosses stand up and ask exactly how they’re supposed to “maximize results for our clients” given what the editors are mistaking for the day’s top news stories.
And you can bet really big money the Dallas Morning News will be doing way more investigative business reporting than ever before under this new organizational structure, especially if, say, an advertiser car dealership is caught in, say, major fraud.
→ B.Dunn, Dec 03, 2009, 07 44 pm
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