Archive for the "Regulatory Compliance" Category

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Understanding US Food and Drug Administration Recalls

The Food and Drug Administration, the agency n charge of regulating the safety of drugs is the Food and Drug Administration, is empowered by the US government to review the application of a pharmaceutical company to manufacture and release to the market any new drug it develops. The FDA also can issue a recall for [...]

FDA Safety Recalls and How They Affect You

Sometimes, there is no guarantee that all products displayed on the shelves of supermarkets or department stores are all made of quality and safety. This is very common when a product has just been launched but because of the convincing packaging, consumers are sometimes led to believe that these possess all the characteristics and qualities [...]

How an FDA Recall Affects You

There is a growing list of drugs that are classified as dangerous and has been attributed to the more than two hundred thousand deaths each year just in the United States alone. Apparently, the main cause why these dangerous drugs are causing a high mortality rate is the fact that some pharmaceutical companies choose to [...]

Understanding FDA Safety Alerts

Have you ever tried to picture out your locality without ever receiving any alerts from FDA for anything at all? This could be unimaginable since FDA is the body responsible to monitor drugs, cosmetics, and other medical and health related products. Without any FDA safety alerts, consumers would just go around buying anything they deem [...]

What You Should Do If Your Prescription Drug is Recalled

The very reason that people take drugs is to be relieved of all the uncomfortable sensation they have going on through their bodies. However, there are times when harmful side effects show in a delayed manner which may sometimes take up to a few years before showing up. When the side effects show up, the [...]

How to Reduce the Burden of Compliance

Today CIO’s and CISO’s are faced with the challenge of attaining or maintaining security controls in order to comply with industry standards, regulations or legislation such as PCI DSS, SOX404, Basel II, and/or Data Protection Act. Alternatively they may ‘just’ be attempting to find evidence in compliance with a set of internal risk policies aligned to [...]

PAT Testing Procedure

Portable Appliance Testing (or PAT Testing) is a legally required method of testing portable appliances. There are many stages that go towards the testing process. It will end with either a pass or fail result. Portable Appliance Testing needs to look at certain safety elements. Amongst the things that can cause the failure is damage [...]

How to Reduce the Burden of Compliance – Part 2

In this the second of a series of three articles on effectively attaining and maintaining compliance levels; the focus of attention turns to the major considerations when evaluating and selecting commercial compliance management tools from the market. THINK HOLISTICALLY The process of becoming compliant covers a broad spectrum of activity — understanding processes, designing applicable [...]

Answering an OFAC Administrative Subpoena

The United States Department of Treasury Office of Foreign Assets Control (“OFAC”) has just sent you an Administrative Subpoena requesting information pertaining to certain activities they suspect you to have been engaged in. What do you do? One of OFAC’s prime intelligence gathering tools is the Administrative Subpoena. Here they ask you to provide a [...]

Mercury Vapor Legislation – Laws and Legalities Regarding the EPA Act 2005

The EPA Act 2005 passed mercury vapor legislation that essentially outlawed the production of these more harmful lights and light fixtures in the United States. As of January 1, 2008, mercury vapor lights cannot be made, marketed, or imported to the United States because of this act. Unfortunately, because of their affordability and bright white [...]