by Toni Clarke, Reuters (via The Chicago Tribune)

A sign for pharmaceutical compounding company NECC, a producer of the steroid methylprednisolone acetate, is seen in Framingham, Massachusetts. (Image credit: Jessica Rinaldi, Reuters)

(Reuters) – U.S. health inspectors found bugs, a flying bird and other unsterile conditions at Ameridose LLC, an affiliate of the Massachusetts compounding pharmacy at the heart of the deadly meningitis outbreak.

Westborough, Massachusetts-based Ameridose was closed on October 10 to allow state and federal investigators to inspect its facilities. On Monday the U.S. Food and Drug Administration released the results of its investigation.

The agency’s report details a list of quality control failures at Ameridose, including a failure to test the potency of its products, a failure to properly classify patient complaints and the use of “vague, canned language” when describing negative patient reactions to its drugs.

The company, an affiliate of the New England Compounding Center, said it is in the process of preparing a full response to the FDA.

“Ameridose’s history shows clearly that we have not had any instance of contaminated products over the course of the past six years, which covers the manufacture and shipment of 70 million units of product,” the company said in a statement. “Ameridose is committed to addressing all observations in order to enhance our existing systems.”

The investigation of Ameridose follows the closure of the NECC, which distributed thousands of vials of a steroid linked to an outbreak of fungal meningitis that has hit 19 states and claimed 32 lives.

Inspectors found that Ameridose failed to investigate customer complaints related to drug potency, under-filled products and syringe volumes. It also failed to classify “patient response” complaints as “adverse events.”

Several such complains referred to the drug oxytocin, used to induce labor in childbirth. One referred to “fetal distress and hyper stimulated uterus.” Another customer called to report an increase in post-partum hemorrhaging. Another reported that a patient had shortness of breath and that “the throat was closing.”

A complaint related to the painkiller fentanyl noted that the patient was “oversedated” and “unresponsive.” Another patient given the blood-thinner heparin experienced a “life-threatening” negative reaction.

Inspectors said buildings used to make, process, pack and hold the drugs were not maintained in a good state of repair. The firm failed to perform a microbiological assessment after “penetrating leaks” were found in a building and water dripping above the clean room.

“During the inspection we observed totes placed in the location of the penetrating leaks containing water,” the inspection report noted. “There is no documented evidence that the leaks were permanently corrected.”

Walls were cracked, corroded and covered with what appeared to be adhesive material in a room where sterile drugs are prepared, the report noted.

Equipment and utensils were not cleaned or sanitized at appropriate intervals to prevent contamination that could alter the safety, identity, quality or purity of the drugs, according to the report.

Certain metal surfaces “were observed to contain what appeared to be brownish structures, atypical in shape,” the report noted.

Moreover, the buildings used “are not free of infestation by rodents, birds, insects and other vermin,” the report said.

Specifically, insects were located in an area where finished sterile product is packaged and stored. The insects were also located within three to 10 feet of the controlled area where sterile products are manufactured.

At least one bird was observed flying in an area where sterile finished product is packaged and stored.

On Friday, Ameridose, which has the same owners as NECC, said it would lay off about 90 percent of its work force. About 650 employees at Ameridose will be affected, as well as 140 employees at Medical Sales Management, a company that provides sales, technology and human resources support to Ameridose.

BILLINGS, Mont. (AP) – A Denver-based oil company has pleaded guilty to violating federal law in the deaths of migratory birds in fluid pits at the company’s oil and gas drilling facilities in Montana, Wyoming and Nebraska and has been fined $22,500.

The U.S. Attorney’s Office in Montana said SM Energy Co. pleaded guilty Wednesday one misdemeanor count of violating the Migratory Bird Treaty Act in each state. U.S. Magistrate Carolyn Ostby also placed the company on probation for a year and ordered it to make a $7,500 payment to the National Fish and Wildlife Foundation.

The case dates back to 2005, when the U.S. Fish and Wildlife Service documented deaths of a dozen migratory birds at uncovered open fluid pits at Nance Petroleum sites in Wyoming. Nance later become an SM Energy subsidiary.

Copyright 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

by Xinhua News Agency

Image credit: US EPA

Mexican President Felipe Calderon on Wednesday announced that the bird flu having broken out four months ago in the western Jalisco state has been “totally controlled.”

“After 68 days with no new cases reported, we are entering the stage of eradication” of the H7N3 virus, Calderon said at the presidential residence.

Mexico will recover very soon from the highly dangerous avian influenza, he said, stressing that the control of this disease is the result of “great effort of the government and producers.”

Among the measures, he said the culling of over 22 million chickens, the establishment of a sanitary cordon and the development of an “effective vaccine against the disease, are crucial to control the virus quickly and decisively.”

In the past months, “around 140 million doses of vaccine have been applied, and we also have a sufficient reserve bank to use if necessary,” the president said.

Thanks to efforts to restore the productive capacity of the farming, Mexico is expected to recover in November the number of laying hens to the level prior to the outbreak of the avian influenza, he said.

Calderon noted that the goal now is to stimulate the creation of new chicken producers’ centers in other parts of Mexico to diversify regional egg production and prevent such an impact in the future. However, Jaime Crivelli, president of the National Poultry Union, criticized the government for minimizing the impact of the bird flu on egg production.

As a response, Calderon said his government acted in time, because otherwise the damage to egg production would have been irreversible in his country, the fifth largest producer in the world and the largest per capita egg consumer.

He announced a support of $16.6 million (215 million pesos)in normalizing egg production and credits for those who want to engage in egg production.

The president noted that so far 65 percent of egg production has been restored. Besides, the country has imported nearly 14,000 tons of eggs, mainly from the United States, to meet demand.

by Richard Wheeler (via Norwich Evening News 24)

The battle to protect Norwich’s historic buildings from feathered invaders has intensified – as officials attempt to defend two more city attractions from their droppings.

How it could look if pigeons attacked Norwich Castle. (Image credit: Norwich Evening News 24)

Proposals to install pigeon-guarding systems have been put forward for the Bridewell and Shirehall, following a successful application for a similar idea at Norwich Castle. Mess on the pavement outside the Shirehall, in Market Avenue, below where the pigeons roost, affects access to the building for visitors according to planning documents from the Norfolk museums service.

The papers add that the droppings are also causing white staining to the stonework, which cleaning is “unlikely to remove”, as well as health and safety issues. At the Bridewell, the documents state the volume of pigeon waste creates a risk of “slipping on wet foul”.

Measures to deter pigeons from sills and ledges in the museum’s central courtyard were installed during a recent £1.5m refurbishment. But the plans reveal these are ineffective in many areas.

There are concerns at both sites that the mess stops workers being able to reach and clean out gutters and pipes to stop them getting blocked. There is a risk water could seep into the walls and damage the buildings’ walls if these are not unblocked.

Posts with thin wire on them are proposed for both buildings. These aim to stop pigeons from being able to roost or perch.

Museum officials are also bidding for cash to fund a similar defence system at Norwich Castle after the city council approved the plan. It is hoped these measures will protect the 11th century structure from further damage. The post and wire system was trialled and also checked by English Heritage before permission was granted, to try and ensure it will not ruin the appearance of the castle.

Stuart Garner, operations manager for Norwich museums, said: “We’ve had the pilot and we all agreed on the best way forward with English Heritage. We’ve got the majority of listed-building consent. Now, it’s preparing the documents for the funding.”

Mr Garner said it was Norfolk County Council’s responsibility to look after the attractions, but the city council has agreed to contribute 30pc toward the costs of pigeon-proofing them. No cost figures have yet to be made public.

Dr Will Fletcher, English Heritage’s inspector of ancient monuments in Norfolk, said it is difficult trying to protect historic buildings from pigeons.

But he said it involved pinpointing the ideal roosting locations and then installing new equipment without damaging the fabric of the building while ensuring it is “sympathetic” to its appearance.

Dr Fletcher said of the Norwich Castle plans: “It can all be taken away without damaging the fabric and leaving the castle intact.

“We will come back six to eight months or a year later down the line to see how effective it’s been.

“We are aware of the fact pigeons can be a problem elsewhere. We’ve talked about the issues, falconry and other options around the town but it pushes it from one place to another.

“There will be an ongoing issue and it’s really something for the people of Norwich to get involved in and we welcome their views.”

Mission Viejo, CA (PRWEB) May 08, 2012

Bird-B-Gone, Inc. leading manufacturer of professional grade bird deterrents would like to announce the launch of their newly designed website.

Bird-B-Gone supplies the commercial, industrial and residential market with effective, humane bird deterrents manufactured in the USA. Beyond offering high quality products with industry leading guarantees, the company prides itself on the level of customer service, support and free training provided to customers.

The new, improved website will be a helpful resource to pest control and wildlife professionals or anyone looking to deter birds from their property. The site offers specific information for nearly every industry affected by pest birds. (more…)

Like everything else you own or manage, buildings require regular maintenance to keep them from deteriorating. Regardless of the size of your building, certain specific tasks must be performed to ensure heating, cooling, ventilation, and air conditioning systems are operating properly and continue to meet health and safety codes. Bird proofing can prevent droppings, nests and other and other bird debris from damaging these important systems–systems that can be very costly to repair or replace.

Likewise, a building’s plumbing systems, drains, drinking fountains, sprinkler systems and the timers that control them must be kept free of bird droppings and other debris to function properly. The same holds true for outdoor walkways, tables and chairs used by employees. Bird proofing will keep disease-carrying droppings from contaminating these areas. They can also prevent costly litigation should someone slip and fall on bird droppings.

Exterior lighting and security cameras must be kept clear and fully functional to ensure the safety of visitors and employees. Bird droppings and nests can obscure and render these systems inoperative unless bird-proofing devices are installed. Similarly, exterior locks, doors and windows can jam up, leaving gaps in a building’s security and resulting in the need for expensive repairs.

Finally, roofs, exterior facades and signage can be seriously damaged by pest-bird droppings and nesting materials. Roofs, especially, can be prohibitively expensive to repair or replace. The acid in bird droppings can quickly eat into painted signs and plastic, ruin expensive entry monuments and artwork, and crumble stone facades. All the more reason to invest in bird proofing before damage occurs.

Bird Proofing Solutions

Today’s bird proofing solutions are humane and highly effective. Poisons and shotguns are out, scientifically designed bird deterrents are in. These are easy to install and virtually maintenance free. Most are visually unobtrusive and balance aesthetics with function.

Bird Spikes Get the Job Done

As an effective bird-proofing device, few deterrents come close to the Bird Spike. Birds have one heck of time trying to land anywhere near them. That’s because the menacing-looking spikes really intimidate most birds. The spikes come in stainless steel or rigid unbreakable polycarbonate. And while they look like they would impale a bird, the blunted spikes are harmless to birds or maintenance crews. Bird spikes can be used to deter a wide range of birds and work quite effectively on rooftops, signs, building ledges and other outdoor areas.

Bird Spiders for Smaller Areas

For smaller nooks crannies, there’s the Bird Spider. Like the bird spike, it keeps pest birds from landing and nesting. While bird spikes are motionless, a spider’s arms whip around in the breeze to catch a pest bird’s eye. Spiders come in different sizes (different length spider arms) to deter different bird species.

(more…)

Unlike homes and boats, commercial buildings suffer damage from pest birds on a grand scale. Commercial  building owners spend millions of dollars every year to deal with problems associated with pest birds. The only viable solution is bird proofing.

Failure to bird proof a commercial building can lead to all sorts of problems. The droppings pest birds leave seriously detract from a building’s appearance. The acid secretion produced by the fungi that live in bird droppings can mar paint and other surfaces. Cleaning and restoring buildings damaged by pest birds can be very expensive. Nests and droppings can, over time, clog gutters and down pipes, causing rooftops to leak or fill with water and possibly collapse. Pest bird nests and droppings can get sucked into ducts, grilles and vents, clogging commercial air conditioning and heating units, permanently damaging these expensive systems.

Bird droppings deposited at commercial building entrances and fire escapes increase the likelihood that pedestrians may slip and fall on them, creating a huge legal liability to commercial property owners. Droppings also spoil finished products in loading bays and storage areas. They ruin the appearance of costly finished goods, metal panels, and stonework. Droppings can also eat into and destroy wood, paper and cardboard packaging of products on pallets or outside storage.

(more…)