Page 164 - CW E-Magazine (5-3-2024)

Special Report

freeing up resources to focus on high- To address that issue, the FDA on recruitment, development, and reten-
risk facilities.” implemented a pilot for conduct- tion of drug investigators who per-
ing unannounced inspection at foreign form inspections overseas. “We will
In fi scal year 2019, the FDA con- facilities, but some say the results have continue to monitor FDA’s progress
ducted the largest number of foreign been mixed. “It is promising to see the towards implementing it,” she said.
inspections in India and China, where FDA implement [its] Foreign Unan-
more than one-third of foreign estab- nounced Inspection Pilot program with Staffi ng is also an issue as it relates
lishments supplying the US market both China and India,” said the Over- to the use of translators when conduct-
were located, according to the GAO sight and Investigations Subcommittee ing foreign inspections. In its January
report. However, beginning in March Chair, Griffi th. “The goal of this pilot 2022 report, GAO reported that FDA
2020, FDA postponed most inspections program is to increase the unannounced has relied on translators provided by
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because of the COVID-19 pandemic. surveillance inspections of foreign the foreign establishments being in-
“Whatever fi tful, halting progress the drug facilities. Since March 2022, the spected, “which investigators told us
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FDA made towards strengthening its FDA has completed 35 unannounced can raise questions about the accuracy
foreign inspection program has been and short-term notice inspections in of information FDA investigators
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undone by the COVID-19 pandemic India. I hope they continue implement- collect,” said GAO’s Denigan-Macauley.
and, to date, the FDA has been slow or ing this program and that it will lead to
IndiaChemTrade provides consolidated trade statistics
ChemImpex, the trade database, tracks, on a daily
unable to get foreign inspections back changes within the FDA for foreign in- Another key issue for FDA is how
basis, exports and imports of chemicals and related
of India. The information provided here is based on the
on track,” said the Oversight and Inves- spections. China, on the other hand, is it will address its backlog of foreign
products through the major ports in India — a vital
annual trade data published by the Directorate General
tigations Subcommittee Chair. Griffi th. a completely different story. The FDA inspections. In its January 2022 report,
source of commercial intelligence. Find out on-line
of Commercial Intelligence and Statistics, Government
the GAO noted that the postponement
of India. The database can be searched by: Chemical
how international markets are moving; where your
Challenges, progress, and actions to take has not completed any unannounced or of inspections because of the
short-notice inspection since the pilot
competitors are exporting and at what price; where Name/Harmonised Code to obtain the consolidated
A key weakness in FDA’s foreign
COVID-19 pandemic led to a backlog of
program was initiated,” he said.
imports are coming from and how
inspection program cited by certain their prices are trade (import or export) in that item; or by Country to
establishments never inspected or not
members of Congress and the GAO is that seamlessly, for a obtain the trade (import or export) in all chemicals and
moving. Download all this data,
Staffi ng issues also are a challenge inspected within fi ve years – categories
related products between India and that country
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foreign inspections are pre-announced, of the FDA to improve its foreign in- for which FDA considers inspections
something the FDA is in part seeking to spection program. The GAO reported mandatory. “We reported that this
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improve. Unlike domestic inspections, that the FDA had persistent vacancies backlog could both extend the interval
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foreign establishments may receive up duct foreign inspections, which included resources FDA has available for other
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to 12 weeks of advance notice of an vacancies among US-based staff high-priority inspections,” said GAO’s
plyers on-line, any time. This unique platform is free to all advertisers in the print version of Chemical Weekly.
inspection due to the logistical and access who conduct foreign inspections and Denigan-Macauley. In line with GAO’s
issues to conduct an inspection. “As a among staff in FDA’s foreign offi ces recommendations, the FDA issued
For more information contact: 022-24044477. Fax: 022-24044450
result, investigators may be less likely located in China and In India. In line a plan for addressing this inspection
Email: corporate@chemicalweekly.com or log on to chemicalweekly.com
to see the true day-to-day operating with GAO’s recommendations, GAO’s backlog, which GAO’s Denigan-
environment of foreign establishments Denigan-Macauley said FDA reported Macauley said “we will continue to
as compared to domestic,” said GAO’s in March 2023 that it had developed a monitor FDA’s progress towards imple-
Denigan-Macauley. plan with six tailored strategies focused menting it.”
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164 Chemical Weekly March 5, 2024
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