security lapse at Robinsons Place, Manila: etc.

Security lapse at Robinsons Place Manila on September 17, 2008. Because of lax security at P. Gil entrance to said mall, deadly weapons could have been brought into said mall. A guard at said entrance didn't inspect well the waist bag a person was using and the boots said person was wearing. Said objects were large enough to contain said objects.

Tips for people suffering from cold and flu:
http://abcnews.go.com/Health/ColdandFluNews/story?id=5808952&page=1

Boosting post-baby weight loss:
http://news.yahoo.com/s/nm/20080916/hl_nm/breastfeeding_weight_dc;_ylt=Ajp9wPbijwhjEiRVdR1hLpTVJRIF

about Metabolic and Cardiovascular Disorders:
http://www.medpagetoday.com/PublicHealthPolicy/EnvironmentalHealth/tb/10924

health news from National Library of Medicine National Institute of Health


* Gastric Bypass Beats Band for Faster Weight Loss (09/16/08)
* Most Women with Osteoporosis Unaware of Raised Fracture Risk (09/16/08)
* Are You At Risk for Deep Vein Thrombosis? (09/16/08)


about leg pain:
http://news.yahoo.com/s/ap/20080915/ap_on_he_me/blood_clots;_ylt=Avwh8ozfTzSTvK3xdTxvTdbVJRIF

about early daycare
http://news.yahoo.com/s/nm/20080916/hl_nm/daycare_asthma_dc;_ylt=AlHgucbhxJn37SmjWvbCJcXVJRIF

Ontario Ministry of Health and Long-Term Care
http://www.health.gov.on.ca/

Emergency Planning

Make an Emergency Plan

Be Prepared:
Make a Plan

Question
Place a check mark next to each item that applies:

Community

1. I know the unique risks of my community.
2. I am aware of my community’s emergency response plan.
3. I know the evacuation route for my home.
4. I am familiar with the schools’ emergency plans.
5. I am aware of the emergency plan for my workplace.

Home
1. The keys to the deadbolts are in a safe and easy-to-remember location.
2. I have smoke and CO detectors on each floor and I have tested them in the last six months.
3. I am aware of an alternate exit for each room on each floor.
4. I know how to turn off the gas/water/electricity.
5. The list of emergency telephone numbers is in a safe and easy-to-remember location.
6. My family and I have identified a meeting place outside the home.

Car
1. I understand the importance of having the gas tank at least half full.
2. I have an emergency survival kit in the car.

My Family and Me
1. I am aware of any special needs my family may have during an emergency.
2. We have emergency plans in place to care for our pets.
3. We have a home evacuation plan.
4. Everyone in the family has a copy of the emergency contact numbers list.
5. We have an emergency kit that is accessible and easily carried.
6. We have an emergency response plan and have discussed it in detail.
7. Someone in our family is trained and knows how to provide first aid.


FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01886.html

FDA News

FOR IMMEDIATE RELEASE
September 16, 2008


Media Inquiries:
Rita Chappelle, 240-753-8603
Christopher Kelly, 240-753-8610
Consumer Inquiries:
888-INFO-FDA

FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India
Actions affect over 30 different generic drugs; cites serious manufacturing deficiencies

The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India.

The Warning Letters identify the agency's concerns about deviations from U.S. current Good Manufacturing Practice (cGMP) requirements at Ranbaxy's manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India.

Because of the extent and nature of the violations, FDA today issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients (API) (the primary therapeutic component of a finished drug product) and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.

The problems at these two Ranbaxy plants relate to deficiencies in the company's drug manufacturing process. These actions are proactive measures that the FDA is taking in order to assure that all drugs that reach the American public are manufactured according to cGMP requirements. While this action does not involve removing products from the market, FDA has no evidence to date that Ranbaxy has shipped defective products. We will continue to monitor the situation.

Today's announcement does not impact products from Ranbaxy's other plants which are not affected by today's actions. FDA has inspected those facilities and, to date, they have met U.S. cGMP requirements for drug manufacturing.

The FDA recommends that consumers continue taking their medications manufactured by Ranbaxy and not disrupt their drug therapy, which could jeopardize their health. Patients who are concerned about their medications should discuss their concerns with their health care professional.

Earlier today, the FDA informed Ranbaxy that until it resolves the deficiencies at each of these two facilities and the plants come into compliance with U.S. cGMP requirements, FDA's drug compliance office will recommend denial of approval of
any New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that list the Paonta Sahib or Dewas plants respectively as the manufacturer of APIs or finished drug products

Ranbaxy is one of the largest foreign suppliers of generic drugs to the United States. The company makes a number of drug products.

The FDA Import Alert covers more than 30 different generic drug products (Drug List) produced in multiple dosage forms and dosage amounts ( i.e., 25 mg, 50 mg, and 100 mg) at these two locations.FDA has evaluated whether these actions would create
any potential drug shortages in the United States, and has determined that other suppliers can meet market demand, with one exception. Because Ranbaxy is the sole supplier to the U.S. of one drug product, Ganciclovir oral capsules (an antiviral
drug), to avoid creating a shortage of the drug, FDA generally will not detain shipments of this product, and plans to arrange for additional oversight and controls until the company resolves these manufacturing issues.

"With this action we are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality," said Janet Woodcock, M.D., director, FDA's Center for Drug Evaluation and Research (CDER).

"The FDA has notified other agencies and health care professionals to make them aware of today's actions so that they can take appropriate action and advise patients as needed." The Warning Letters issued today document the results of FDA investigations at these two sites.

One Warning Letter addressed problems at Ranbaxy's Dewas facility found during an inspection conducted by FDA in early 2008.

During that inspection, FDA investigators documented significant cGMP deviations in the manufacture of sterile and non-sterile finished products and violations with respect to the manufacture and control of APIs. Specific areas of concern included the following aspects of the firm's quality control program:

* The facility's beta-lactam containment program (measures taken to control cross-contamination), which appeared inadequate to prevent the potential for cross-contamination of pharmaceuticals;
* Inadequate batch production and control records;
* Inadequate failure investigations; (A failure investigation is done to address any manufacturing control or product rejection to determine the root cause and prevent recurrence); and,
* Inadequate aseptic (sterile) processing operations.

The second Warning Letter addressed the Paonta Sahib facility following an inspection at its Batamandi unit, also in early 2008.This inspection documented various cGMP deficiencies, including the following:

* The lack of assurance responsible individuals were present to determine the firm was taking necessary steps under cGMP;
* Inaccurate written records of the cleaning and use of major equipment;
* Incomplete batch production and control records; and,
* Inadequate procedures for the review and approval of production and control records for drug products.

Following the two inspections, FDA provided Ranbaxy with a separate list of inspectional findings for each of the facilities.

In mid-April and May, Ranbaxy responded in writing to these findings in lengthy submissions to FDA. The agency then evaluated its findings, Ranbaxy's responses, and the firm's overall inspectional history, an evaluation that required substantial time
due to the complex scientific and technical nature of both the identified deficiencies, particularly at the Dewas site, and the firm's responses. Ultimately, FDA concluded that the firm's responses were not adequate and that the Warning Letters were the appropriate regulatory response.

"Today's actions are clearly warranted by the serious violations established by FDA's investigations at these two sites," said Deborah M. Autor, director, CDER's Office of Compliance, FDA. "Until the company addresses these deficiencies, APIs and finished drug products from these plants will remain on the Import Alert, and we will not approve any Abbreviated New Drug Applications or New Drug Applications that list either of the two facilities as the manufacturer of APIs or finished drug products."

This represents the second time in less than three years FDA has issued a Warning Letter to Ranbaxy. In 2006, FDA cited Ranbaxy for violations of U.S. cGMP at its Paonta Sahib facility.

The FDA will continue to work with Ranbaxy's Dewas and Paonta Sahib plants to resolve these issues.


Links to the Warning Letters:
http://www.fda.gov/foi/warning_letters/s6922c.htm
http://www.fda.gov/foi/warning_letters/s6923c.htm

Link to Consumer Questions and Answers:
http://www.fda.gov/cder/drug/infopage/ranbaxy/qa.htm


Tips for a germ-free office
http://www.nfib.com/object/IO_32918.htm