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# CDER Caught Up on Domestic Pre-approval Inspections: Cavazzoni
- URL: https://www.fdaweb.com/cder-caught-up-on-domestic-pre-approval-inspections-cavazzoni/
- Published: 2022-06-16T12:00:00.000Z
- Updated: 2026-09-14T17:48:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152095

Despite all the challenges the Covid-19 pandemic has thrown at FDA, the agency’s drug Center has still been able to meet its user fee goal dates, and all domestic NDA pre-approval inspections that had been earlier delayed due to the pandemic have now been completed, CDER director **Patrizia Cavazzoni** told the Food and Drug Law Institute’s (FDLI) annual meeting 6/14 in Washington, DC. She said CDER and ORA have adapted to using alternative tools, like remote regulatory assessments for drug manufacturing establishments ([see earlier story](https://www.fdaweb.com/fda-updates-on-inspection-backlog-caused-by-covid/)). “Obviously we use these alternative tools to the fullest extent, however there are always situations where we have no choice but to physically inspect the facility in order to make a decision on the application,” she said. CDER-regulated BLA pre-licensure inspections have also been completed, with the exception for those needing inspections in India and China.

Cavazzoni said China inspection access “remains a problem because of the zero Covid policy that exists there, which makes a physical inspection still extremely difficult, and so these alternative tools will be particularly important at this juncture.” She said that in some situations, FDA inspectors have had to quarantine in foreign military barracks for two to four weeks before being able to go to a facility.

Cavazzoni acknowledged that its inspection alternative tools will remain part of FDA’s tool belt in the post-pandemic world. They may not be used as often or as intensely as during the pandemic, “but there will always be situations where there are emergencies or natural disasters where we may not be able to get to a facility, and so I think that it will be important to continue to view these tools as being part of the gamut of modalities that we have to evaluate facilities,” she told FDLI. She also shared with the audience that CDER has completed more than 1,000 remote regulatory assessments for drug manufacturing establishments, and more than 200 remote regulatory assessments under its bioresearch monitoring program. By using the alternative tools, the number of facilities needing pre-approval and pre-license inspections has been reduced by about 52%, she added.

Regarding CDER’s compliance activities, she said there has been growing use of alternative tools to support GMP Warning Letter issuance. With Covid travel restrictions lowering the number of FDA inspections, the agency shifted to alternate tools, such as sampling, or 704(a)(4) records requests, she said, adding that FDA issued almost the same amount of GMP Warning Letters in fiscal year 2021 as in previous years.

Cavazzoni said the drug compounding compliance/enforcement program continues to be an area of focus. “We think that is this is one of the areas where we still have some risk, which is inherent to both the characteristics of the facilities as well as the scope and limitations in our authorities,” she said. CDER is also continuing to focus on clinicaltrials.gov enforcement, which supports transparency in clinical trial registration and results reporting. She said that so far in fiscal year 2022, the Center has issued 12 pre-notice of noncompliance letters, and one notification of noncompliance. “To date, these actions have been effective in achieving voluntary compliance,” she added.

Meanwhile, a new joint [CDER/ORA report](https://www.fda.gov/media/158918/download?ref=fdaweb.com) on inspection follow-up shows just how the pandemic has negatively impacted certain compliance activities. The agency has a goal to issue a final facility classification letter within 90 days after an inspection closes, but in fiscal year 2021 the agency issued these to only 70% of inspected facilities within that timeline. In contrast, FDA in 2019 issued 87% of final facility classification letters within 90 days of inspection closing. Another goal FDA missed calls for it to complete regulatory actions on Official Action Indicated inspections within six months of an inspection closing — it completed only 48% of these under the timeline in FY 2021, compared with 74% in FY 2019.

The report noted that the pandemic impacted the day-to-day operations and inspections under a CDER/ORA [Concept of Operations](https://www.fda.gov/drugs/pharmaceutical-quality-resources/questions-and-answers-integration-fda-facility-evaluation-and-inspection-program-human-drugs-concept?ref=fdaweb.com) agreement. According to the report, the agreement’s “measures enable transparency to facilities regarding inspection outcomes, which can enable timely implementation of corrective actions and continued access to high quality medicines and offer industry faster access to data which could inform business decisions to help identify suitable suppliers. Communicating timely, complete, and concise decisions to manufacturers support the availability and accessibility of quality products, as well as the potential to accelerate novel technologies and new therapies to market.”