| 21 CFR 1.502(a) | Maintain, follow FSVP | 4,881 | 3,571 |
| 21 CFR 123.6(b) | No HACCP plan | 4,805 | 2,784 |
| 21 CFR 110.35(a) | Cleaning and sanitizing operations | 4,593 | 3,222 |
| 21 CFR 123.11(b) | Sanitation monitoring documentation | 4,492 | 2,726 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 4,331 | 3,334 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 3,905 | 3,147 |
| 21 CFR 110.35(c) | Lack of effective pest exclusion | 3,734 | 3,004 |
| FDCA 402(a)(4) | System for administration of drugs | 3,650 | 1,917 |
| 21 CFR 110.20(b)(4) | Spacing of equipment | 3,141 | 2,373 |
| 21 CFR 211.192 | Written record of investigation incomplete | 2,801 | 1,798 |
| 21 CFR 211.22(d) | Procedures not in writing, fully followed | 2,413 | 1,844 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 2,355 | 1,894 |
| 21 CFR 110.20(b)(7) | Screening | 2,342 | 2,019 |
| 21 CFR 312.60 | Informed consent | 2,172 | 1,862 |
| 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures | 2,151 | 1,742 |
| 21 CFR 110.40(a) | Precluding contaminants | 2,116 | 1,685 |
| 21 CFR 123.6(c)(2) | Monitoring - none | 2,078 | 1,642 |
| 21 CFR 123.6(c)(1) | Food safety hazards | 2,025 | 1,651 |
| 21 CFR 820.30(g) | Design validation - user needs and intended uses | 1,961 | 1,377 |
| 21 CFR 820.75(a) | Lack of or inadequate process validation | 1,884 | 1,475 |
| 21 CFR 123.6(c)(3) | Critical limits | 1,816 | 1,380 |
| 21 CFR 820.184 | Lack of or inadequate DHR procedures | 1,793 | 1,517 |
| 21 CFR 820.90(a) | Specific non-conforming product procedures | 1,786 | 1,499 |
| 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved | 1,781 | 1,329 |
| 21 CFR 803.17 | Lack of Written MDR Procedures | 1,701 | 1,544 |
| 21 CFR 110.10(b)(6) | Failure to wear | 1,643 | 1,372 |
| 21 CFR 123.6(c)(4) | Monitoring - adequacy | 1,641 | 1,236 |
| 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures | 1,632 | 1,345 |
| 21 CFR 123.11(c) | Sanitation Records | 1,593 | 1,307 |
| 21 CFR 117.35(c) | Pest control | 1,564 | 1,362 |
| 21 CFR 110.80 | Testing | 1,559 | 1,311 |
| 21 CFR 123.6(c)(5) | Corrective action plan | 1,524 | 1,156 |
| 21 CFR 110.80(b)(2) | Manufacturing conditions | 1,504 | 1,312 |
| 21 CFR 123.12(a)(2) | Importer verification | 1,497 | 975 |
| 21 CFR 110.20(b)(5) | Safety lighting and glass | 1,475 | 1,254 |
| 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition | 1,462 | 1,013 |
| 21 CFR 211.160(b) | Scientifically sound laboratory controls | 1,449 | 1,119 |
| 21 CFR 117.80(c) | Process Control Measures | 1,446 | 1,284 |
| 21 CFR 117.10 | Personnel | 1,437 | 1,248 |
| 21 CFR 110.20(a)(1) | Harborage areas | 1,434 | 1,223 |
| 21 CFR 211.25(a) | Training--operations, GMPs, written procedures | 1,407 | 1,137 |
| 21 CFR 820.100(b) | Procedures | 1,381 | 1,202 |
| 21 CFR 117.130(a)(1) | Hazard Analysis - Identification of Hazard | 1,325 | 1,124 |
| 21 CFR 110.80(a)(1) | Water quality -- wash, rinse, convey food | 1,307 | 1,129 |
| 21 CFR 110.80(b)(7) | Equipment, containers, utensils | 1,302 | 1,168 |
| 21 CFR 530.11(d) | ELDU - producer causes Illegal drug residue | 1,284 | 1,158 |
| 21 CFR 123.6(c)(6) | Verification procedures - none/frequency | 1,278 | 998 |
| 21 CFR 123.6(d) | Signed and dated | 1,248 | 1,033 |
| 21 CFR 820.25(b) | Training records | 1,225 | 1,053 |
| 21 CFR 110.10(b)(3) | Not washed/sanitized when appropriate | 1,220 | 1,055 |
| 21 CFR 312.62(b) | Case history records- inadequate or inadequate | 1,183 | 1,120 |
| 21 CFR 117.40 | Equipment and utensils - Design and maintenance | 1,140 | 1,036 |
| 21 CFR 820.20(c) | Management review participants | 1,137 | 997 |
| 21 CFR 211.67(b) | Written procedures not established/followed | 1,135 | 877 |
| 21 CFR 211.166(a) | Written program not followed | 1,125 | 904 |
| 21 CFR 123.8(a)(3) | Verification - record review - frequency | 1,116 | 866 |
| 21 CFR 606.100(b) | Written SOPs available for use by personnel | 1,098 | 725 |
| 21 CFR 117.135(a)(1) | Sanitation preventive controls - Implement | 1,095 | 786 |
| 21 CFR 123.9(a) | Records entries - timing | 1,073 | 812 |
| 21 CFR 211.113(b) | Validation lacking for sterile drug products | 1,066 | 608 |
| 21 CFR 110.80(b)(1) | Teardown equipment/thorough cleaning | 1,048 | 893 |
| 21 CFR 110.37(e) | Running water at suitable temperature | 1,036 | 977 |
| 21 CFR 820.40 | Procedures not adequately established or maintained | 1,026 | 923 |
| 21 CFR 820.30(i) | Design changes - validation vs. verification | 1,001 | 863 |
| 21 CFR 110.35(d) | Failure to clean - general | 1,000 | 872 |
| 21 CFR 110.37(b)(3) | As source of contamination | 976 | 873 |
| 21 CFR 117.20(b) | Plant construction and design | 952 | 868 |
| 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance | 948 | 790 |
| 21 CFR 111.205(a) | Master manufacturing record - unique formulation | 943 | 751 |
| 21 CFR 211.110(a) | Written in-process control procedures | 936 | 711 |
| 21 CFR 820.70(a) | Production processes | 928 | 823 |
| 21 CFR 820.72(a) | Equipment suitability & capability | 913 | 783 |
| 21 CFR 111.103 | Written procedures - quality control operations, reprocessin | 909 | 726 |
| 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA | 904 | 760 |
| 21 CFR 110.10(b)(9) | Precautions against contamination--micro, foreign substances | 899 | 814 |
| 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs | 890 | 691 |
| 21 CFR 211.100(b) | SOPs not followed / documented | 883 | 714 |
| 21 CFR 110.35(b)(2) | Storage requirements | 870 | 794 |
| 21 CFR 108.25(c)(2) | Process filing | 859 | 655 |
| 21 CFR 530.11(a) | Withdrawal period | 855 | 619 |
| 21 CFR 211.165(a) | Testing and release for distribution | 850 | 708 |
| 21 CFR 211.68(b) | Written record not kept of program and validation data | 837 | 666 |
| 21 CFR 211.22(a) | Lack of quality control unit | 835 | 746 |
| 21 CFR 211.68(a) | Written calibration / inspection records not kept | 816 | 697 |
| 21 CFR 110.20(b)(1) | Sufficient space | 809 | 707 |
| 21 CFR 1.505(a)(2) | Evaluation - performance, risk | 799 | 724 |
| 21 CFR 820.181 | DMR - not or inadequately maintained | 795 | 699 |
| FDCA 501(a)(5) | Use of veterinary prescription drug(s) without a prescription | 792 | 611 |
| 21 CFR 117.37 | Sanitary facilities and controls | 789 | 742 |
| 21 CFR 123.10 | HACCP training or qualification | 770 | 640 |
| 21 CFR 110.10(b)(4) | Unsecured jewelry | 751 | 663 |
| 21 CFR 110.93 | Storage/transportation of finished goods (deterioration) | 747 | 681 |
| 21 CFR 820.198(c) | Investigation of device failures | 733 | 630 |
| 21 CFR 1.506(a)(1) | Unapproved supplier procedures - importer established | 724 | 626 |
| 21 CFR 211.160(a) | Lab controls established, including changes | 710 | 576 |
| 21 CFR 110.35(d)(5) | Shown to be effective | 708 | 618 |
| 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient | 706 | 518 |
| 21 CFR 211.63 | Equipment Design, Size and Location | 698 | 584 |
| 21 CFR 1.506(b) | Supplier verification - follow written procedures | 695 | 625 |
| 21 CFR 110.10(b)(7) | Storage of personal items | 692 | 600 |
| 21 CFR 123.8(a)(2)(ii) | Calibration - adequacy | 687 | 560 |
| 21 CFR 1250.67 | Signs for non-potable water | 681 | 462 |
| 21 CFR 820.30(a) | Design control - no procedures | 679 | 608 |
| 21 CFR 820.80(d) | Quarantine of finished devices | 670 | 615 |
| 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures | 667 | 601 |
| 21 CFR 117.35(d) | Sanitation of food-contact surfaces - Frequency | 658 | 600 |
| 21 CFR 110.40(b) | Seams on food contact surfaces | 648 | 584 |
| 21 CFR 820.30(f) | Design verification - unresolved discrepancies | 648 | 567 |
| 21 CFR 1.506(d)(1)(i) | Verification activity frequency | 641 | 547 |
| 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance | 634 | 557 |
| 21 CFR 110.37(e)(1) | Suitable locations | 633 | 598 |
| 21 CFR 111.553 | Written procedures - product complaint | 612 | 538 |
| 21 CFR 120.6(b) | Sanitation monitoring | 612 | 430 |
| 21 CFR 1.504(a) | Hazard analysis written | 606 | 559 |
| 21 CFR 110.37(e)(5) | Signs | 602 | 567 |
| 21 CFR 1.504(b)(1) | Hazard analysis biological, chemical, physical | 598 | 527 |
| 21 CFR 111.255(b) | Batch record - complete | 590 | 425 |
| 21 CFR 211.188 | Prepared for each batch, include complete information | 586 | 517 |
| 21 CFR 123.7(a) | Corrective action per predetermined plan | 583 | 459 |
| 21 CFR 114.100(b) | Processing and production - required information | 582 | 450 |
| 21 CFR 110.37(e)(2) | Hand cleaning and sanitizing preparations | 579 | 548 |
| 21 CFR 110.37(e)(3) | Hand drying | 579 | 548 |
| 21 CFR 110.80(b)(5) | Work-in-progress | 577 | 509 |
| 21 CFR 111.453 | Written procedures - holding | 565 | 510 |
| 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities | 559 | 510 |
| 21 CFR 211.160(b)(4) | Written calibration procedures | 554 | 462 |
| 21 CFR 110.37(b)(5) | Cross contamination | 553 | 525 |
| 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier | 551 | 413 |
| 21 CFR 114.80(b) | Visible code | 551 | 473 |
| 21 CFR 803.50(a)(2) | Individual Report of Malfunction | 549 | 456 |
| 21 CFR 111.75(c) | Specifications met - verify; finished batch | 542 | 407 |
| 21 CFR 1.506(e)(1) | Verification activity before import, periodically | 541 | 489 |
| 21 CFR 110.10(b)(1) | Suitable outer garments | 540 | 497 |
| 21 CFR 117.4 | Training of employees and records | 540 | 491 |
| 21 CFR 110.10(b)(8) | Personal food/drink/tobacco | 538 | 499 |
| 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures | 537 | 347 |
| 21 CFR 606.160(a)(1) | Person performing, test results, interpretation | 533 | 351 |
| 21 CFR 123.6(a) | Hazard analysis | 531 | 466 |
| 21 CFR 117.93 | Storage and Distribution | 519 | 484 |
| 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition | 513 | 397 |
| 21 CFR 820.70(c) | Environmental control system periodic inspections | 512 | 426 |
| 21 CFR 111.503 | Written procedures - returned dietary supplement; salvaged | 510 | 463 |
| 21 CFR 114.80(a)(1) | Use of preservatives (S) | 509 | 433 |
| 21 CFR 120.8(a) | No HACCP plan | 507 | 369 |
| 21 CFR 111.70(b)(1) | Specifications - component identity | 490 | 381 |
| 21 CFR 110.20(b)(6) | Fans/air blowing equipment | 487 | 429 |
| 21 CFR 820.30(j) | Design history file | 471 | 430 |
| 21 CFR 117.126(a)(1) | Food safety plan | 458 | 412 |
| 21 CFR 123.6(c)(7) | Records values/observations | 455 | 389 |
| 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System | 452 | 360 |
| FDCA 501(a)(2)(A) | Vermin, production area/adjacent areas | 450 | 115 |
| 21 CFR 110.80(b)(8) | Metal / extraneous materials | 448 | 403 |
| 21 CFR 117.135(c)(3) | Sanitation preventive controls - Appropriate (Adequate) | 440 | 401 |
| 21 CFR 1.505(b) | Supplier approval - evaluation | 436 | 408 |
| 21 CFR 211.180(e)(2) | Review of problem drugs | 436 | 361 |
| 21 CFR 820.90(b)(2) | Retesting and reevaluation of reworked product | 429 | 388 |
| 21 CFR 606.100(c) | Thorough investigations | 417 | 313 |
| 21 CFR 110.37(f) | Odor, attractant for pests, harborage | 413 | 380 |
| 21 CFR 211.80(a) | Written Procedures Not Followed | 413 | 364 |
| 21 CFR 820.70(i) | Validation of changes to automated process software | 409 | 361 |
| 21 CFR 820.40(a) | Not approved or obsolete document retrieval | 406 | 372 |
| 21 CFR 114.83 | Scheduled process establishment | 405 | 339 |
| 21 CFR 117.145(a) | Sanitation Controls Monitoring Proced: Establish Implement | 402 | 297 |
| 21 CFR 803.50(a)(1) | Report of Death or Serious Injury | 402 | 343 |
| 21 CFR 211.165(e) | Test methods | 401 | 364 |
| 21 CFR 110.10(b)(5) | Impermeable (S) | 397 | 368 |
| 21 CFR 110.37(a) | Suitable temp. and pressure | 396 | 357 |
| 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements | 396 | 369 |
| 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. | 396 | 362 |
| 21 CFR 211.170(b) | Reserve samples identified, representative, stored | 393 | 326 |
| 21 CFR 812.100 | No investigator protection - subject rights, safety, welfare | 375 | 311 |
| 21 CFR 211.84(d)(1) | Identity Testing of Each Component | 371 | 330 |
| 21 CFR 312.62(a) | Unused drug disposition (investigator) | 370 | 352 |
| 21 CFR 110.40(e) | Lack of thermometer | 357 | 328 |
| 21 CFR 110.20(b)(2) | Contamination with microorganisms, chemicals, filth, etc. | 355 | 331 |
| 21 CFR 111.70(b) | Specifications - components | 353 | 343 |
| 21 CFR 820.80(e) | Maintained as part of the DHR {see also 820.184} | 352 | 327 |
| 21 CFR 111.83(a) | Reserve sample - collect, hold | 349 | 315 |
| 21 CFR 820.30(e) | Design reviews performed following schedule | 345 | 330 |
| 21 CFR 110.35(b)(1) | Unacceptable toxic compounds | 344 | 326 |
| 21 CFR 820.198(e) | Records of complaint investigation - UDI | 342 | 321 |
| 21 CFR 117.35(e) | Sanitation of non-food-contact surfaces - Manner and frequency | 340 | 313 |
| 21 CFR 820.30(c) | Incomplete, ambiguous, conflicting design requirements | 339 | 313 |
| 21 CFR 1271.50(a) | Responsible person to determine, document | 338 | 231 |
| 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence | 337 | 253 |
| 21 CFR 117.80(a) | Plant operations - Precautions | 335 | 319 |
| 21 CFR 111.255(a) | Batch record - every batch | 333 | 281 |
| 21 CFR 820.250(b) | Sampling plans | 331 | 307 |
| 21 CFR 211.194(a) | Complete test data included in records | 330 | 291 |
| 21 CFR 211.113(a) | Procedures for non-sterile drug products | 328 | 295 |
| 21 CFR 211.182 | Written records kept in individual logs | 324 | 291 |
| 21 CFR 113.100(b) | Review of processing and production records | 321 | 244 |
| 21 CFR 211.58 | Buildings not maintained in good state of repair | 320 | 285 |
| 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations | 315 | 309 |
| 21 CFR 111.475(b)(1) | Written procedures - holding; distributing | 314 | 290 |
| 21 CFR 211.137(a) | Expiration date lacking | 313 | 273 |
| 21 CFR 211.42(c)(10)(v) | Cleaning System | 313 | 259 |
| 21 CFR 108.25(c)(1) | Registration | 307 | 280 |
| 21 CFR 110.40(c) | Non food-contact equipment in processing area | 307 | 284 |
| 21 CFR 118.4 | Written SE plan not implemented/followed | 307 | 196 |