Wednesday, 16 February 2022 14.00 - 15.30 h
The US FDA reports deficiencies during inspections in the so-called Form 483s. These reports are partly public and are trending, and the FDA subjects them to trending by key points. The evaluation of the last year 2020 shows a significant increase in inspection deficiencies with regard to equipment. This includes defects in equipment design, size, placement, and deficiencies in maintenance and cleaning. In 2019, equipment still ranked 11th on the list of drug observations. In 2020, process equipment moved up to No. 5 - followed by No. 6, which again separately lists deficiencies in maintenance and cleaning.
You can find the overviews sorted by year on the FDA website. In the Excel tables, the areas Drugs, Biologics, Devices, Food etc. are listed as separate tabs.
The Form 483 reports are handed over to the inspected company after the inspection. The company has 15 days to comment in writing on the findings. This statement is supposed to give the company the opportunity to correct the deficiencies found. It is advisable to start a CAPA case for each inspection deficiency (finding). Here, a root cause investigation should take place, corrective actions should be defined and a time schedule for this should be defined. These documents should be part of the response, for example as attachments. The response should be sent to the FDA within 15 days (working days) - i.e. three weeks. A written update should be provided every four to six weeks, and the completion of the corrective action should also be communicated. This may result in a re-inspection. If the FDA does not agree with the remedial actions or progress mentioned, a Warning Letter may follow, which then requires further action and may lead up to a ban on importation of drugs into the US.