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Department of Labor’s Wage and Hour Division Targets Restaurants in LA, San Francisco, and Portland OR

Time Posted on April 19, 2012 | author Posted by Marc Sanchez | comments 0 comments

The US Department of Labor’s Wage and Hour Division announced in three separate press releases a new initiative to target the restaurant industry in Los Angeles, San Francisco and Portland Oregon. The Agency aims to prevent minimum wage, overtime, record-keeping and child labor violations. Restaurants in these cities would be well advised to seek counsel and ensure compliance. As restaurants owners in New York discovered defending claims from [...]
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Looking for a FSMA Update?

Time Posted on March 13, 2012 | author Posted by Marc Sanchez | comments 0 comments

If you are looking for a FSMA update I have been invited to present an audio conference for FX Conferences in April. Details below:   Audio conference highlights The Foreign Supplier Verification Program (FSVP) automatically takes effect in 2013 under the terms of the Food Safety Modernization Act. Congress had set a one-year deadline of [...]
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EC’s Commissioner for Health and Consumer Policy Calls for Stricter Safety Controls, Postmarketing Surveillance for Medical Devices

Time Posted on February 10, 2012 | author Posted by Marc Sanchez | comments 1 comments

The European Commission’s (EC) Commissioner for Health and Consumer Policy John Dalli called for the EC to “look at the sector of medical devices as a whole,” saying that both the EC and national agencies need to review how medical devices are approved in the EU in a speech given to the press on 9 February. [...]
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Creekstone Farms Premium Beef Workers File Class-Action Suit For Unfair Compensation

Time Posted on February 7, 2012 | author Posted by Marc Sanchez | comments 0 comments

The Associated Press is reporting that a federal judge has granted conditional class-action status to a lawsuit filed on behalf of an estimated 700 workers at a slaughterhouse in Kansas. Workers at a Kansas packing plant are seeking unpaid wages and overtime from Creekstone Farms Premium Beef on behalf of the 700 employees at the firm’s Arkansas [...]
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IRS Issues Regulations on $20 billion Medical Device Tax

Time Posted on February 6, 2012 | author Posted by Marc Sanchez | comments 1 comments

Proposed regulations from the IRS on the 2.3% excise tax on medical devices, designed to generate $20 billion as part of the Patient Protection and Affordable Care Act, were announced on Friday. The health care reform law added Section 4191 to the Tax Code, imposing an excise tax on the sale of certain medical devices by the manufacturer, [...]
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FDA and Industry Reach Agreement in Principle on Medical Device User Fees (MDUFMA)

Time Posted on February 1, 2012 | author Posted by Marc Sanchez | comments 0 comments

The FDA announced today that it reached an agreement on the third re-authorization of a medical device user fee program. The news follows the Agency missing its second deadline to submit a proposal to Congress for the Medical Device User Fee & Modernization Act (MDUFMA), which is set to be renewed this year. The negotiations and details are still forthcoming, [...]
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FDA Takes Action Against New York Cheese Manufacturer

Time Posted on January 31, 2012 | author Posted by Marc Sanchez | comments 0 comments

The FDA announced today that it was seeking an injunction in Federal Court against a NY cheese manufacturer. The Agency is asking a federal court to prevent a New York cheese manufacturer from operating because of a history of unsanitary conditions and producing cheese in a facility contaminated with Listeria monocytogenes bacteria. According to a complaint for permanent injunction filed by [...]
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“Pink Slime” a Matter of Safety or Unhealthy Adulteration?

Time Posted on January 31, 2012 | author Posted by Marc Sanchez | comments 1 comments

Multiple news outlets are reporting on McDonald’s announcement that it was no longer using the controversial ground beef additive known as “pink slime” in its hamburger recipe. Pink slime is the name given to a process created by Beef Products Inc where trimmings (scraps of fatty pieces left over in the slaughterhouse after all the good cuts of [...]
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US FDA detains Brazil, Canada Orange Juice for Fungicide (Carbendazim)

Time Posted on January 31, 2012 | author Posted by Marc Sanchez | comments 2 comments

Food Court reported in early January on a FDA notification that the Agency would step up testing for a fungicide that has been found in low levels in orange juice (read more). News came late on Friday of 9 import shipments detained by the FDA after testing positive for the fungicide carbendazim. Reuters reported on the detention of three shipments [...]
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Vitaflo USA Announces Nationwide Voluntary Recall of Renastart 14.11 oz (400g)

Time Posted on January 31, 2012 | author Posted by Marc Sanchez | comments 0 comments

The FDA released a voluntary recall notice from Vitaflo USA. Vitaflo USA is recalling Renastart 14.11 oz (400g) cans, Batch Number 12832 (shown on underside of can), because some of the product shipped throughout the United States during the period December 29, 2011 through January 26, 2012 has been incorrectly labeled.  Renastart is a powdered medical food [...]
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• Counseled start-up on formation, FDA establishment registration, device listing, and 510(k) & international device approval (CE Mark, China, Japan etc.);
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