With the news that domestic inspections are back on track the question comes with what is the backlog and how long will it take to slug through the outstanding inspections work? Question number 2 is then what do we anticipate seeing from these new domestic inspections?
With it being over a year+ (March 2020) since the Agency suspended inspections, except for those considered mission critical, and was getting out with any frequency to domestic facilities, it is quite possible that firms, under the pressure of COVID restrictions, firms may have let systems slip a bit. Some firms ask the FDA for relief on some aspects of operations, while others were diligent in trying to keep their operations up to compliance standards. How well did they do? We will need a month or two to see what the new landscape looks like and how many significant FDA Form 483s are issued and how many Warning Letters follow.
Personally, I believe we will see a distinct spike in enforcement activity resulting from the hang over of the COVID pandemic’s impact on the industry. Firms should be reevaluating their readiness for inspection as the FDA inspectorate gears up their operations. As for foreign inspections, it still is mission critical only. Once this changes and the Agency is back on full speed inspectional operations, we are likely to see the same results from the international pharmaceutical sector.