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FDA officials said most of the warning letters issued in fiscal year 2022 for GMP issues were the result of on-site inspections, reversing the trend
of enforcement actions triggered by the use of alternative tools during the pandemic.
However, Jeffrey, director of the three program departments of the Office of Regulatory Affairs (ORA), Drug Quality Operations
Meng asserted that the FDA faced "incredible challenges" in responding to the backlog of inspections shelved during the pandemic, providing an update on compliance activities at the PharmaLink conference hosted by the Professional Association for Regulatory Affairs (RAPS) and the Association of Food and Drug Officials (AFDO
).
Meng also provided insight
into the direction the FDA will focus on in future inspections.
On-site inspection: the gold standard
On-site inspection: the gold standardIn fiscal year 2022, FDA issued 62 warning letters and 23 drug-related import alerts, excluding actions
related to dispensing.
In FY2022, the number of warning letters issued by on-site inspections increased significantly; 42 (67.
7%) warning letters came from on-site inspections, 16 (25.
8%) from sample testing, and 4 (6.
5%) from remote record reviews
.
In fiscal year 2021, fewer warning letters were issued for on-site inspections as the pandemic caused many inspections to be suspended, with the exception
of inspections deemed mission-critical.
In FY 2021, 21 (25.
3%) of such warning letters came from on-site inspections
.
The remainder came from alternative tools: 59% from sample testing, 13.
3% from remote record review, and 2.
4% from rejecting record request requests
.
Meng said on-site inspections are the "gold standard because it provides a more complete picture of a company's operations," while other methods only give the FDA a view of "a small portion of a company's operations.
"
Challenges ahead
Challenges aheadFDA faces the daunting challenge of addressing the backlog of domestic and international on-site inspections at sites considered high priority but not mission-critical
.
"Looking ahead to 2023 and beyond, FDA has resumed all day-to-day domestic operations and is currently resuming normal foreign inspections
.
Doing business globally will be an incredible challenge
.
”
Meng said the FDA has made "incredible progress" in addressing the domestic backlog.
The Company shall take appropriate control measures
The Company shall take appropriate control measuresMeng said that to avoid enforcement actions, companies should have appropriate controls and oversight
of their products.
He gave two warning letters as examples of what can happen when these controls are not implemented
.
The first example is Pharmatech LLC, a Florida manufacturer of pharmaceuticals and dietary supplements that manufactures and sells the drug Diocto used to treat constipation
Liquid
。 In July 2016, the FDA conducted an inspection following an
outbreak of Burkholderia cepacia infection associated with the use of the product.
The FDA found that water samples taken from the company's water system tested positive for the bacteria and issued warning letters
.
The company told the FDA it repaired the water system, but failed to do so
.
According to a statement from the Ministry of Justice, in June 2022, CEO Raidel
Figueroa pleaded guilty to "conspiring to defraud the FDA, falsifying records in FDA investigations, obstructing FDA proceedings, and distributing adulterated drugs.
"
Contamination leads to multiple adverse events, including death; Several wrongful death lawsuits are pending
.
Another case involved a dental technology company
in Illinois.
Investigators found that during an inspection conducted after a massive recall of the drug in October 2020, the company's Paroex
The 0.
12% chlorhexidine mouthwash sample contained Burkholderia cepacia complex in quantities so large that it could not be counted
on aerobic plates.
"I draw attention to these examples because I firmly believe that in 2022 we should no longer experience deaths
related to ADE (adverse pharmaceutical events), liquid products in medicines," Meng said.
Please ensure that you have proper control and supervision
over the product.
”
FDA will rely on the new Inspection Compliance Program Manual
FDA will rely on the new Inspection Compliance Program ManualLooking ahead, Meng said, according to the FDA's recently updated Compliance Program Manual (CPGM) on GMP Pre-Approval and Manufacturing Inspections, the FDA
Management responsibility and risk management
will be scrutinized in the forthcoming inspection.
In September, the FDA updated two compliance program manuals covering pre-approval inspection (PAI) and GMP surveillance inspections, which explain alternative inspection tools and expectations for nitrosamine assessment prior to approval of CPGM
, FDA uses four criteria to decide whether to proceed with a PAI: these criteria include a company's readiness for commercial production, whether the company is compliant with the application, whether there are data integrity issues, and the company's commitment
to quality.
Meng said CPG is key and a guiding light for FDA to perform inspections, the FDA is using a risk-based model to decide which companies to inspect next, and the FDA expects the industry to formally implement risk management programs to better ensure the quality system
of the products it produces.
