Unannounced FDA inspections have started in India, not China

Regulatory NewsRegulatory News | 07 April 2022 |  By 

Judith McMeekin

The US Food and Drug Administration (FDA) unannounced foreign inspections program has resumed in India but is still paused in China due to local COVID-19 restrictions, Judith McMeekin, FDA associate commissioner for regulatory affairs, said on 6 April during a webinar sponsored by the Alliance for a Stronger FDA.
Members of Congress have expressed concern that FDA’s drug inspection program is inadequate to meet the meet the growth in foreign drug manufacturing facilities and that – unlike domestic inspections – only features announced inspections. An appropriations bill last year directed the agency to start a pilot program of short unannounced and short-term inspections in India and expand it to China. (RELATED: Unannounced FDA inspections in India, China to begin soon, Regulatory Focus, 15 December 2021).
The bill allotted $3.5 million to the pilot with a targeted start date of early 2022.
McMeekin said that while the program has started in India, conducting inspections has been difficult because many of these sites are either located in remote areas or are located in certain restricted economic zones.
“When we conduct unannounced inspections at a facility in a remote area, we are forced to rely on local forms of transportation” which may be more unreliable than transportation in major metropolitan areas.
Also, some of these facilities are in a “special economic zone” and entry into these areas is not permitted without an escort. “Conducting unannounced inspections for firms in the special economic zones can really delay our investigators at the entry point until someone from the firm is contacted and can escort our investigators,” she said. “This has been a challenge in conducting these inspections, but this is something that we have to deal with.”
Staffing challenges
McMeekin also noted that meeting adequate staffing levels at ORA has also “been challenging” in response to a question on employee hiring.
“It can be challenging to maintain staffing levels to meet our annual workplan, our goal is to make sure that we have a diverse and highly capable and adaptable workforce, we do continue to leverage all of the hiring authorities,” including hiring veterans, she said, adding that “a priority for the agency is to hire investigators who can conduct foreign inspections.”
The agency received additional funding to hire investigators through the 21st Century Cures Act, yet this funding is limited to hiring inspectors in the medical product area. “While we are very grateful for the Cures hiring authorities, it has created some challenges for ORA because Cures is only for medical products. So inspections on the food side are not eligible to receive that.”
She also noted that the challenges of foreign travel make it difficult to retain staff.
“Foreign travel is rigorous, and it really requires the ability to endure long trips abroad,” she said, where one foreign inspection can last three weeks. “They work constantly and sometimes traveling to multiple countries within the same trip. The staff may travel many hours in coach and upgrades are covered by the employee personally. In January, the foreign cadre will come up to 18 weeks per travel per year.”
When will onsite inspections resume?
When asked when the agency plans to resume in-person foreign inspections, McMeekin said “we have never stopped conducting foreign mission-critical inspections.”
The agency is now shifting towards expanding onsite foreign inspections to include those that are not mission-critical. “For a while, we were only doing mission-critical and that left a subset of other inspections that were not mission-critical.”
McMeekin said there were plans to resume domestic surveillance inspections and non-mission critical foreign inspections in early February, but these plans were delayed due to the “highly contagious” nature of the omicron variants (RELATED: FDA to resume routine domestic surveillance inspections next week, Regulatory Focus, 4 February 2022).
On the domestic side, the agency is now pivoting to conducting priority surveillance inspections as the result of “COVID-19 cases in a state of decline.”
Domestic inspections will continue to be preannounced until the pandemic is over. “We are still in a pandemic, and we do announce that for safety issues so that we call in advance to make sure there are no outbreaks at the facility,” she said.


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Tags: FDA, Inspections

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