FDA Consulting assistance with FDA Regulations, FDA Compliance and FDA Validation
The U.S. customs and FDA work closely and recently while doing a spot examination of a mail shipment of foreign drugs, the US Customs revealed that such shipments usually contain counterfeit and unapproved drugs that create severe safety problems. This joint operation by customs and FDA was carried out to help customs and FDA stop counterfeit and potentially unsafe drugs from entering the United States. Ideally this is the task of compliance programs.
CFSAN and the effects FDA compliance failure
FDA compliance programs are documents created by agencies that guide Agency field offices for investigations, inspections, sample collections, sample analysis, and regulatory activities in defined program areas, such as domestic seafood and pesticides in domestic foods. FDA compliance is necessary for the businesses selling food, cosmetic and medical products in the US. FDA compliance standards issued by CFSAN are updated every 3 years but for some programs they are re-issued sooner due to changes in procedures, regulatory concerns, etc. One such standard for compliance is FDA's Quality Systems Regulation (QSR). Complaint handling and reporting requirements are an integral part of the FDA QSR.
For businesses dealing with food products, FDA anticipates that it, or a state agency acting on its behalf, will discover a domestic facility's failure to be registered during a routine food safety inspection. During the inspection the inspector will check for FDA validation with respect to the validity of the registration. If the facility is not registered, then that is brought to the notice District FDA Compliance Branch.
Regulatory action can take place in cases of continuing failure to register and in cases which may cause a threat to food supply, adverse health or death to people or animals. In addition, FDA may also consider the failure to register as an additional charge in a legal action on other statutory violations.
For foreign facilities, the FDA law generally enforced is based on the registration requirements in accordance with the policies set out in the "Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness Response Act of 2002" (revised November, 2004)"
To avoid such experiences, FDA Registrar Corp helps companies comply with U.S. FDA standards and regulations such as:
* U.S. FDA Food Facility Registration
* U.S. Customs and FDA Prior Notice(Forms to ship food and beverages to the USA)
* U.S. Food Labeling Regulations
* U.S. Food Canning Establishment Registration (FCE) and Process Filings (SID)
* U.S. FDA Medical Device Establishment Registration
* U.S. FDA Medical Device Listings
* U.S. FDA Cosmetic Registration
* U.S. FDA Cosmetic Formulation Filings, etc.
FDA compliance made quick and easy!
It is often difficult to comprehend FDA standards and regulations. So, FDA Registrar Corp makes it convenient for companies to overcome the hurdles of complex paperwork required by FDA law. This FDA consulting support is particularly helpful to non-U.S. companies that may need to overcome language barriers, time barriers and cultural barriers with regard to U.S. government paperwork and requirements.
At www.fdaregistrar.com you can receive information about FDA regulations as well as FDA validation requirements.
Sara Caplan
LOS ANGELES - A state Court of Appeal has ruled the West Los Angeles entertainment litigation firm Christensen Glaser can be sued for wrongful termination by a legal secretary who claims she was fired for refusing to inflate client bills.
The decision, by the 2nd District in Los Angeles, is just the latest news to beset the firm that recently changed its name to Christensen, Glaser, Fink, Jacobs, Weil & Shapiro after partner Louis R. "Skip" Miller bolted to start his own shop. Managing partner Terry Christensen currently is under indictment in the Anthony Pellicano wiretapping scandal.
On Wednesday, name partner Patricia Glaser denied the firm padded its legal bills.
Reversal of Trial Judge
"We don't engage in any funny billing, ever," she said.
The appellate decision, handed down Thursday, reverses summary judgment by Judge Maureen Duffy-Lewis, of the Los Angeles Superior Court. The 2nd District, however, upheld summary judgment in favor of name partner Robert Shapiro because he did not hire secretary Pauletta James.
The appeals court found that James could sue the high-profile firm for "wrongful termination in violation of public policy and intentional infliction of emotional distress."
Not Hired by Shapiro
"We conclude that the trial court erred when it ruled that (1) James could not identify a public policy sufficient to support her cause of action for wrongful termination in violation of public policy, and (2) the intentional infliction of emotional distress cause of action is barred by the exclusivity provision of the workers' compensation scheme," the court wrote. "However, James failed to show that the trial court erred when it ruled that Shapiro was not her employer."
Justice Judith M. Ashmann-Gerst wrote the opinion; Justices Victoria M. Chavez and Kathryn D. Todd concurred.
James claims she witnessed attorney Shapiro and former attorney Sara Caplan fabricating legal bills that were then sent to clients. She claims she was terminated, on Jan. 28, 2003, after reporting the alleged illegal activity to firm management.
Lawyers for the firm and Shapiro claim in court documents that James was legitimately terminated due to poor performance. She talked too much to her colleagues and was difficult to work with, they say. Lawyers for the firm say they also learned James ran into difficulties at other firms where she worked after she was terminated from the Christensen firm.
The appeals court rejected that assertion as irrelevant but returned the case to Duffy-Lewis to consider Christensen Glaser's motion for summary judgment on James's request for punitive damages.
Christensen has been involved in some of Hollywood's most bruising brawls of the last decade. They won judgments against the Walt Disney Co. and actress Nicole Kidman. The firm represents billionaire Kirk Kerkorian in many matters. Terry Christensen is accused in a federal indictment of hiring Pellicano to wiretap Kerkorian's ex-wife in the middle of a nasty child support proceeding.
James' lawsuit is not the first time the firm has been accused of fraudulent billing practices. In 1998 former partner Andrew White testified in court that a colleague had come to him with concerns Miller was inflating client bills. The firm denied those allegations.
On Wednesday, Glaser vehemently defended the firm.
"People are just looking for ways to make stories, and you can put any spin on that you want, but the firm has done nothing wrong," she said.
Sale Of Life Settlement Policy
Life settlement is a sale transaction which takes place in the life settlement or life insurance policy for cash payment more than the surrender value. Life settlement policy provides all benefits and premium at the time of policy maturation. It is sale of life settlement policy made to the third party for immediate cash benefit. Sale of life settlement policy happens when the owner feels that the life insurance policy is no more for him. The sale of life settlement policy can be made only to the third party or the life Settlement Company and get a cash payment for the policy. The amount received will varies as per the age, life expectancy and value of the policy of the policy holder.
The policy holder sells the life settlement policy to the buyer, when he wants to utilize the money at the time of death. The life insurance company agrees to purchase the life insurance policy for the face value. People sell the life settlement policy for many reasons. Depending upon the life expectancy, value and age of the policy holder, the life settlement policy will be sold in the market for the reasonable prices. The life settlement firm holds the reasonability of the life settlement policy and pays the premium abiding to the life settlement policy. The individual sells the policy, when he finds no more in using the policy and expects to die sonly. Life settlement policy varies in different policy and the distinction lies in two different policies.
As per the tax implication by the government and regulations for the life settlement policies fetches the cash payment. There are cases arises in the sale of life settlement policy, that the policy holder finds scarce financial resources for the survival and to improve his standard of living, the holder sells the policy to the life settlement firm. Most of the people sell their life settlement policy, when he feels that he won’t live any more. Life settlement firm agrees to purchase the life settlement policy for the reasonable amount. There is more number of life Settlement Company available to purchase life insurance policy on the agreed rate of value from the people who offer life settlement policies.
This life settlement company helps the policy holder who faces the problem from improper health condition, senior settlements and so on. The life insurance company facilitates the policy owners to sell the life insurance policy properly. Life settlement policy is issued as per the age, life expectation and life insurance policy value and so on. There are more buyers and life insurance company available in the secondary market to buy life settlement policy from the policy holder.
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