Drug industry pushes FDA to solve growing inspection backlog - Politico

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I had to read this snippet very carefully, and re-read it several times to make sure I completely understood the statistics reported. I suggest you do the same.

According to the article:

"From March through September, FDA inspected just three plants outside the U.S., well below the 600-plus it visited in each of the prior two years, the Government Accountability Office said last month. FDA has also struggled to keep up with inspections within U.S. borders, conducting just 52 during the same seven-month period last year, compared with roughly 400 each in 2019 and 2018."

Read the full source article: Drug industry pushes FDA to solve growing inspection backlog - Politico

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FDA Abroad - Pharmaceutical Executive

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Updated June 4, 2025

Sadly, the original link broke.

--  the original post follows below ---

Read the full article: FDA Abroad - Pharmaceutical Executive:

"In India, America's second largest global source of API and finished drug products, some 1,965 manufacturing facilities export to the US, but only around 600 sites are registered with CDER, said Atul Agrawal, supervisory consumer safety officer at FDA's India office. Drug manufacturing capability in India doubled to represent 12% of total US drug imports in 2012, up from 6% in 2008. "India is a major player in the prescription drugs Americans take on a daily basis," said Agrawal, much to the envy of Chinese nationals everywhere. And yet, FDA's operation in India currently consists of five full-time Americans, and two locally employed staffers, spread across two offices, one in New Delhi and one in Mumbai."

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Warning Letters (2012 – Q1 2014) Show FDA’s GMP Enforcement Shifting Overseas | IPQ Newsletter

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Warning Letters from 2012 – Q1 2014 Show FDA’s GMP Enforcement Focus Shifting Overseas; Foreign Labs Draw Particular Attention | IPQ Newsletter:

"In 2012, for the first time, foreign warnings began outpacing those issued domestically. Between 2012 and the first quarter of 2014, 48 drug GMP warning letters were issued internationally compared to 44 in the U.S. [Editor's Note:  At the end of the story is a chronological listing of all 92 of the drug GMP warning letters issued between the beginning of 2012 and the first quarter of 2014, categorized into U.S. and International. The key concerns that each of the warning letters address and links to the letters themselves are provided.]"

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