FDA Opens First Overseas Office in China
Nov 26, 09:40 AM
We’ve all read and heard about the numerous headlines regarding contaminated products produced in China this year, for those who aren’t keeping track below is a sample of issues found in the past 18 months:
- Children’s toys containing lead paint
- Toothpaste containing toxic sweetener found in anti-freeze products
- Contaminated Pet Food, leading to death of pets
- Milk Products containing Melamine (resulting in numerous children in China becoming ill)
- Contamination of batches of Heparin (a blood thinner) which lead to numerous deaths around the globe
These headlines have brought about a negative view of not only Chinese manufacturers but of the US authorities responsible for overseeing the safety of consumers. The leading US authority in the spotlight has been the Food and Drug Administration (FDA). These extreme and numerous incidents have highlighted some major gaps and concerns around how the FDA conducts business. Many were shocked to learn about the under resourced status of the FDA which for many years had lead to lengthy timelines between scheduled inspections of manufacturing sites, many times resulting in over a decade between inspections, particularly of overseas manufacturing sites.
We are all aware of the numerous industries outsourcing manufacturing overseas in order to cut costs, and the pharmaceutical industry is not the exception. Each year more companies are outsourcing the manufacturing of critical products overseas, resulting in the need for the FDA to expand their services to audit overseas sites.
On a positive note, the FDA announced on Wednesday, November 19, 2008 that the FDA has opened their first overseas office in Beijing, China. In addition to the Beijing office, the FDA will open offices in the cities of Shanghai and Guangzhou, as well as two new offices scheduled to be opened in India next month (December 2008).
In China, eight American employees, with expertise in food, medicine and medical devices, will work with Chinese government agencies and producers to raise standards and guarantee quality before goods are bound for the United States. That said, the tasks placed before these individuals are overwhelming to say the least.
— test Aug 13, 03:40 PM #
— Dentist Costa Mesa Sep 24, 02:35 AM #