By Category

Findings by category

What regulators cited, grouped by topic. These are the axes that recur in inspections — aseptic processing, laboratory controls, deviation investigations — so you can compare them with your own site's weak points.

Aseptic processing and sterility assurance 3,600 findings · 1,336 documents Other quality system 3,539 findings · 2,032 documents Equipment and facility 2,821 findings · 1,892 documents Laboratory and QC controls 2,029 findings · 1,500 documents Deviation, CAPA, and investigation 1,812 findings · 1,496 documents Stability and storage 1,306 findings · 1,149 documents Material and supplier control 1,291 findings · 1,102 documents Quality unit oversight 993 findings · 868 documents Complaint and recall handling 730 findings · 635 documents Contamination control 678 findings · 570 documents Labeling and packaging 662 findings · 594 documents Computer system validation 654 findings · 622 documents Training and personnel 640 findings · 610 documents Process validation 569 findings · 498 documents Regulatory reporting and change control 525 findings · 517 documents Documentation and records 361 findings · 317 documents Cleaning validation 284 findings · 273 documents Validation and qualification 191 findings · 181 documents Environmental monitoring 135 findings · 113 documents Data integrity 66 findings · 60 documents

To read a whole document

3,305 inspection documents are grouped by agency and year. Open a document to see every finding from that inspection.