Tag: Inspections

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Health

Pandemic Forces F.D.A. to Sharply Curtail Drug Firm Inspections

Pandemic Forces F.D.A. to Sharply Curtail Drug Company Inspections

Remote exam advocates say they can do the same thing virtually. Peter Miller, president of New Jersey-based Dynamic Compliance Solutions, which helps life science companies comply with FDA regulations, says his remote audit kit can do an excellent inspection. The kit includes a tiny 360-degree camera that an on-site host carries on a tripod while the investigator watches on a computer screen.

“The inspector can say, ‘I see a stack of boxes over there. Can we get a little closer I would like to see if they have the right stickers, ”he said. “I believe the examiner should be in control of what he sees. We’re doing a live stream, an unrecorded broadcast. “

Industry lawyers believe the FDA is too picky about the current backlog to refuse remote inspections. Mark I. Schwartz, a former FDA assistant director who oversaw inspections by the agency’s Center for Biologics Evaluation and Research, believes wider use of remote inspections is overdue. Mr Schwartz believes remote inspections, if done properly, will produce results similar to face-to-face visits – which he said more than a dozen of his customers are dying to do.

“To suggest that being there makes a big difference is a fallacy,” said Schwartz, now a director at Hyman, Phelps & McNamara, a law firm with a large practice in the pharmaceutical industry. At best, according to Schwartz, the on-site investigators only see around 15 percent of a company, even if they are there in person.

The subject caught the attention of Congress. Dr. Denigan-Macauley, due to testify Tuesday before the budget subcommittee that oversees FDA Representative Sanford Bishop, a Georgia Democrat who chairs the panel, said, “The pressure to ensure the FDA continues to assess safety and security The effectiveness of the drug supply is growing day by day. ”

While public health experts have been hit by the sharp decline in inspections, most believe virtual inspections are a poor substitute for in-person reviews.

“Remote inspections are just not going to make it,” said Dr. Carome. “Often times the FDA identifies serious problems and when you are away they go undetected.”

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Business

FAA orders inspections of Boeing 777s after engine failure on United flight

FAA orders inspections of Boeing 777s after engine failure on United flight

Residents take photos of debris that fell from the engine of a United Airlines aircraft in the Broomfield neighborhood outside of Denver, Colorado on February 20, 2021. A United Airlines flight suffered a fiery engine failure shortly after taking off from Denver on Feb. 20 en route to Hawaii, where massive debris is falling on a residential area before a safe emergency landing, officials said.

Chet Strange | AFP | Getty Images

United Airlines announced on Sunday that 24 of its Boeing 777s will be temporarily decommissioned after one of the aircraft suffered an engine failure over the weekend.

The head of the Federal Aviation Administration announced on Sunday that the agency would order the inspection of some Boeing 777 jetliners powered by the same Pratt and Whitney engine, the PW4000.

The Japanese aviation authority has ordered airlines to suspend flights from aircraft with this type of engine until further notice, according to the FAA. United is the only US airline with this type of engine in its fleet, the agency added.

United Flight 328, a Boeing 777-200 bound for Honolulu, landed at Denver International Airport shortly after take-off on Saturday afternoon after the right engine failed.

No one was injured in the flight, which carried 229 passengers and 10 crew members, but debris, including part of the engine cover, fell in nearby Broomfield, Colorado.

Federal investigators said their initial investigation found two of the correct motor’s fan blades were broken.

The National Transportation Safety Board said one of the engine’s fan blades broke near its root, while another broke halfway. Other engine fan blades were also damaged, the NTSB said in an initial report late Sunday.

“We checked all available safety data after yesterday’s incident. Based on the initial information, we concluded that the inspection interval for the hollow fan blades, which applies only to this engine model, which is only used in Boeing 777 aircraft, has been extended should be, “FAA Administrator Steve Dickson said in a statement.

United has another 28 of these aircraft in its fleet that are currently in storage. Airlines parked or retired dozens of planes after demand plummeted due to the Covid-19 pandemic.

Engine makers Pratt and Whitney, a unit of Raytheon Technologies, did not immediately respond to a request for comment.

Similar incidents

Such incidents are rare but have occurred in recent years.

In February 2018, another United Airlines 777-200, equipped with Pratt and Whitney PW4077 engines, suffered an engine failure over the Pacific Ocean near Hawaii after a fan blade broke. This comes from an NTSB report published in June. The flight made it safely to Honolulu with 364 passengers and 10 crew members.

In April 2018, a passenger was killed when a fan blade broke off the engine of a Southwest Airlines Boeing 737, broke a window and briefly sucked the passenger outside.

Categories
Business

F.A.A. Orders Inspections on Boeing 777 Jets After Engine Failure

F.A.A. Orders Inspections on Boeing 777 Jets After Engine Failure

The chief of the Federal Aviation Administration said Sunday that one day after a dramatic engine failure over Colorado, he is calling for “immediate or intensified inspections” of all Boeing 777 aircraft with a particular Pratt & Whitney engine model.

Also on Sunday, United Airlines, the only American airline affected by the FAA regulation, announced that they are currently temporarily putting on the ground the 24 Boeing 777 aircraft currently in service in their Pratt & Whitney-powered fleet will.

The FAA’s announcement came shortly after its counterpart in Japan ordered the airlines there not to fly the aircraft, which affected 32 jets operated by All Nippon Airways and Japan Airways. Both Japanese and American orders are only for Boeing 777s with Pratt & Whitney PW4000 engines.

“We reviewed all available security data following yesterday’s incident,” FAA Administrator Steve Dickson said in a statement. “Based on the initial information, we came to the conclusion that the inspection interval for the hollow fan blades, which apply only to this engine model and are only used in Boeing 777 aircraft, should be extended.”

The Colorado episode that involved United Airlines Flight 328 on Saturday resulted in no reported injuries, but the plane threw debris over three neighborhoods before safely landing in Denver.

In a statement on Sunday, United said: “Safety remains our top priority – for our employees and our customers.” It went on, “This is why our pilots and flight attendants receive extensive training to prepare and manage incidents like United Flight 328. We continue to pride ourselves on their professionalism and unwavering commitment to safety in our daily operations and in emergencies that happen. “

Mr. Dickson said the FAA is working with its counterparts around the world and that its security experts meet with Pratt & Whitney and Boeing “late into the evening” to complete details of the required inspections. According to the agency, only airlines in the USA, Japan and South Korea operate Boeing 777s with the affected Pratt & Whitney PW4000 engine model.

A spokesman for Japan Airways said the airline stopped using the 13 engine-equipped Boeing 777s in its fleet before the aviation authority issued its policy. Only three scheduled flights were affected. The airline announced last year that it would remove all 13 aircraft from its fleet by early next year.