FDA to Ramp Up Unannounced Inspections at Foreign Facilities

Contact Your Elected Officials

The agency conducts thousands of inspections outside the United States each year, but many are told ahead of time.

The U.S. Food and Drug Administration (FDA) will be conducting more unannounced inspections at facilities outside the country, the agency announced on May 6.

The FDA conducts about 3,000 inspections of foreign facilities each year, but many facility operators are informed of the inspections weeks or even months ahead of time.

“For too long, foreign companies have enjoyed a double standard—given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning,” Dr. Marty Makary, the FDA’s commissioner, said in a statement. “That ends today.”

The FDA said it intends to expand unannounced inspections at facilities that manufacture a range of goods, including food and medicine. According to the FDA, the expansion will “help expose bad actors—those who falsify records or conceal violations—before they can put American lives at risk. ”

The move builds on an FDA pilot program that tested more unannounced inspections in China and India.

Some U.S. lawmakers, including Sens. Rick Scott (R-Fla.) and Jim Justice (R-W.Va.), had recently asked the FDA to conduct more unannounced inspections.

Investigators with the FDA previously told the Government Accountability Office that the downsides of letting facilities know before inspections are conducted include giving them time to clean up and implement new operating procedures. Twelve of the 18 inspectors who spoke to the office said that unannounced inspections are generally better.

The office recommended that the FDA increase the number of inspections of foreign facilities in 2008 and found that the FDA was conducting many more domestic inspections than foreign inspections in 2010. In 2016, the office said the FDA had increased the number of foreign inspections, but that many facilities manufacturing drugs that enter the United States were never inspected.

The FDA suspended virtually all foreign inspections after the COVID-19 pandemic started, although it later resumed the work.

Dr. Janet Woodcock, a former FDA official, told lawmakers in 2019, before the pandemic started, that the FDA typically gives notice for foreign inspections because of logistics such as securing visas, “and partly because of the high costs of conducting foreign inspections.”

By Zachary Stieber

Read Full Article on TheEpochTimes.com

The Epoch Times
The Epoch Timeshttps://www.theepochtimes.com/
Tired of biased news? The Epoch Times is truthful, factual news that other media outlets don't report. No spin. No agenda. Just honest journalism like it used to be.

The Real Reason Why the Left is Unhinged

Nine out of thirteen of the original states required you to be a Bible believing Christian to serve in government at the time of the founding.

The Sacrificial Lambs of the Riyadh Standup Scene

Which is the greater injustice: jailing political dissidents, or millions dead from pharma crimes with no accountability for those responsible?

No Kings Exposes Odd Things!

The “No Kings” protests held around the nation are not grassroots spontaneous people’s protests but are highly organized events by paid provocateurs.

President Trump Needs Much Better Protection

President Trump faces threats from foreign adversaries and domestic radicals prone to violence, people suffering from severe “TDS.”

Science Has Finally Come For Transgenderism

British biologist Richard Dawkins said “trans women are men,” calling transgender ideology a movement that undermines biological truth.

Texas Appoints Higher Education Ombudsman to Enforce DEI Violations

Texas is moving to enforce bans on DEI practices in universities and potentially restrict college courses focused on gender and race.

House Judiciary Chair Refers Ex-CIA Director John Brennan for Criminal Prosecution

House Republicans referred ex-CIA Director John Brennan to AG Pam Bondi for prosecution over the 2016 probe into alleged Russian–Trump collusion.

FBI Has Arrested 28,000 Violent Criminals Since Jan. 20: Trump

President Trump praised the FBI for doing an “incredible job,” citing thousands of arrests and major disruptions of criminal activity nationwide.

White House Ballroom Project Breaks Ground

Demolition began Oct. 20 on the White House East Wing to make room for Trump’s planned ballroom, with parts of the structure already removed.

Trump Calls off Meeting With Putin, White House Says

White House says Secretary Rubio and Russia’s Lavrov had a productive call; no further meetings or Trump-Putin talks are planned soon.

President Signs Rare Earth Agreement With Australia’s PM

President Trump hosted Australian PM Albanese at the White House, where both leaders signed a new agreement on rare earth mineral cooperation.

Trump Says Insurrection Act Is ‘Strongest Power a President Has’

President Trump detailed plans to invoke the Insurrection Act to address rampant crime, calling it the “strongest power a president has.”

Army Corps of Engineers to Pause $11 Billion in Projects During Shutdown: Vought

Russ Vought, director of the White House’s OMB, has added to the growing pile of federal projects paused during the government shutdown.
spot_img

Related Articles

Popular Categories

MAGA Business Central