FDA Struggles To Keep Products From Foreign Sources Safe

This is required reading for consumers, and for professionals working in the GXP regulated industries (obtaining supplies, food, drugs, etc. from foreign suppliers). Gardiner Harris, a correspondent in The New York Times’s Washington bureau, writes about the very dangers and risk that are lurking out there in this NY Times news article, "The Safety Gap." The article is extremely well written and is full of anecdotes, statistics, and critical analysis that will make you think twice about the food and drugs that all of us are personally using. Here's what made me cringe . . .

1. It worries me that contributors to the story wanted to remain anonymous. It seems to me that perhaps the problem is much bigger than folks are willing to admit.
2. I'm guessing that the contaminated heparin from China incident is probably just the tip of a massive iceberg.
3. No surprise, the FDA is underfunded, understaffed, and ill-equipped to deal with the pent-up demand for foreign plant inspections.
4. It appears there is a danger that foreign plants are less committed to quality standards, and in some cases demonstrate a lack of ethical behavior.
5. I could go on, but it's much better for you to read the news article.

Let the buyers beware (that means us as consumers, and companies partnering with foreign plants).

Previous Posts:
The Health, Drug, Prescription, and GMP Supersite: FDA Finds It Hard To Inspect Foreign Drug Manufacturing Plants

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