Just like moving a house or an office, some things are bound to be lost in the shuffle. However, unlike an office or house move, this process is going to take a while. Look for ongoing development and training as field offices are realigned over the next few years. The second development in the world of FDA inspections focuses specifically on the pharmaceutical industry. FDA currently inspects facilities around the world to ensure pharmaceutical drugs and drug components produced in different countries follow the standards required for sale and distribution in the US.
However, FDA simply does not possess the resources to inspect the entire global supply chain. Many foreign inspections have raised eyebrows in recent years due to breaches in current good manufacturing practices cGMPs. International inspections are costly and time consuming, which has put pressure on resources and international inspectors.
Five percent of those inspected facilities led to an Official Action Indicated classification. Other countries are also expending resources to inspect facilities that provide products to their citizens, and thus the idea of exchanging information arose, and mutual reliance on one of the inspections conducted on a facility.
The agreement also includes surveillances and under certain conditions, pre-approval inspections of marketed human drug facilities within the US and EU. These capability assessments are done country by country in the EU, since the EU itself has differing inspection standards among its member countries.
This is important since the EU inspection model is for two inspectors, each from a different member country, to inspect a facility. As of November , eight joint assessments will have been completed, and information sharing will move forward. FDASIA also enhanced our inspectional authority by requiring facilities to provide, upon request, records or other information in lieu of or in advance of an inspection.
In , FDA began to shift its investigator workforce to cover foreign facilities and to rebalance allocation between domestic and foreign inspections. Still, the Agency did not have adequate staffing and financial resources for foreign inspection coverage. With new resources, FDA has been able to inspect some facilities that previously had not been inspected. In addition, 52 or six percent of the facilities had refused inspection; [6] 37 or four percent of the facilities were inaccessible to FDA investigators because they were unable to travel to them e.
Figure 4. The Agency uses the model to calculate a score for every facility in its Catalog using risk-based factors. Factors in the SSM include:. If the three factors that are fairly static for a facility inherent product risk, facility type and patient exposure are used to risk rank facilities, for inspections conducted from December to June , the median time between inspections was 2. In general, all high-risk facilities were inspected with about the same frequency regardless of location.
See Figure 5. Figure 5. FDA inspected high-risk manufacturing facilities more frequently than medium- or low-risk facilities, and medium-risk facilities more frequently than low-risk facilities, across all countries or regions. In general, all facilities in a risk category were inspected with about the same frequency, regardless of location. Not surprisingly, with more frequent inspections directed to higher-risk facilities since , FDA uncovered some deficiencies, particularly in foreign facilities that had not been inspected as frequently as domestic ones prior to the inception of FDASIA and GDUFA.
Figure 6. The majority of final inspection outcomes for manufacturing facilities making human drugs were acceptable, meaning that they were classified as having No Action Indicated or Voluntary Action Indicated. However, India had a lower percentage of acceptable outcomes than other countries and regions. These were outcomes as of August for the most recent inspection of facilities that were in the Catalog as of July Both foreign and domestic drug manufacturers must meet the same regulatory requirements in terms of complying with established quality standards CGMPs.
These tools include warning letters, import alerts, injunctions, and seizures. If a foreign facility is found to have quality problems serious enough for FDA to classify it as OAI, the Agency can place a facility on Import Alert to prevent drugs from the facility from legally entering the United States.
Under our current authorities, foreign-based manufacturers of certain drugs can legally ship drugs to the United States without ever having been inspected by FDA. For example, last month, we issued a warning letter to a discount retailer for receiving OTC drugs produced by foreign manufacturers with serious violations of CGMPs.
The majority of the foreign facilities involved had distributed drugs to the United States prior to FDA inspections. The inspection of drug manufacturing facilities relies on the collaboration of two organizations within FDA: the Office of Regulatory Affairs ORA , which contains the field force of investigators who conduct the inspections, and CDER, which includes compliance officers who review inspection reports that are initially recommended as OAI and for-cause inspections to determine the final classification and whether appropriate regulatory action is required.
CDER also includes reviewers who evaluate applications for marketing approval and post-marketing changes. ORA has recently completed a multi-year effort to implement a specialized inspectorate focused on human drugs.
The planning for this integration began in in a Program Alignment initiative. As part of this effort, FDA redesigned processes to enhance the efficiency and effectiveness of classifications of inspection classifications See Figure 7.
Depending on the particular circumstances, including remediation efforts made at the facility, CDER may reclassify the inspection. Figure 7. Process for classifying surveillance inspection outcomes after implementation of the ConOps. Implementation of the ConOps has helped improve consistency in evaluation of inspection observations, classification of the inspection, and has reduced the time frames for taking enforcement action. In , the concurrence rate had risen to 73 percent. Figure 8.
Dictionary: Investigators conduct on-site inspections of regulated foreign establishments to proactively ensure the safety and efficacy of products manufactured abroad and sold in the USA. Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons.
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