21 CFR Lookup

The 165 sections of 21 CFR that FDA investigators cited in posted inspection citations, FY2009 to Oct 20, 2026. Each opens the regulation's text, its citations by year and the sites cited.

Most Cited Sections

Inspections citing any paragraph of the section, all years.

All Cited Sections

Most cited first; Ended OAI is the share of classified inspections citing the section that ended Official Action Indicated

Section	Product	Inspections citing	Ended OAI
21 CFR 820.100Lack of or inadequate procedures	Devices	6,052	19%
21 CFR 820.30Design Validation - Risk analysis not performed/inadequate	Devices	5,714	26%
21 CFR 820.198Lack of or inadequate complaint procedures	Devices	5,535	19%
21 CFR 211.22Procedures not in writing, fully followed	Drugs	3,470	28%
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures	Devices	3,167	20%
21 CFR 211.160Scientifically sound laboratory controls	Drugs	2,969	27%
21 CFR 820.70Process control procedures, Lack of or inadequate procedures	Devices	2,769	23%
21 CFR 211.100Absence of Written Procedures	Drugs	2,558	28%
21 CFR 211.192Investigations of discrepancies, failures	Drugs	2,552	29%
21 CFR 820.80Lack of or inadequate final acceptance procedures	Devices	2,524	24%
21 CFR 211.67Written procedures not established/followed	Drugs	2,438	29%
21 CFR 820.90Nonconforming product, Lack of or inadequate procedures	Devices	2,434	20%
21 CFR 820.75Lack of or inadequate process validation	Devices	2,407	25%
21 CFR 803.17Lack of Written MDR Procedures	Devices	2,244	23%
21 CFR 820.20Management review - Lack of or inadequate procedures	Devices	2,124	22%
21 CFR 820.22Quality audits - Lack of or inadequate procedures	Devices	2,076	21%
21 CFR 211.165Testing and release for distribution	Drugs	1,899	40%
21 CFR 820.184Lack of or inadequate DHR procedures	Devices	1,888	20%
21 CFR 211.84Reports of Analysis (Components)	Drugs	1,770	33%
21 CFR 211.166Lack of written stability program	Drugs	1,706	38%
21 CFR 606.100Establish, maintain and follow manufacturing SOPs	Biologics	1,703	3%
21 CFR 211.42Environmental Monitoring System	Drugs	1,648	56%
21 CFR 211.68Calibration/Inspection/Checking not done	Drugs	1,597	24%
21 CFR 820.40Procedures not adequately established or maintained	Devices	1,596	20%
21 CFR 211.25Training--operations, GMPs, written procedures	Drugs	1,535	25%
21 CFR 211.188Prepared for each batch, include complete information	Drugs	1,450	28%
21 CFR 820.25Training - Lack of or inadequate procedures	Devices	1,343	23%
21 CFR 211.113Procedures for sterile drug products	Drugs	1,235	45%
21 CFR 211.198Complaint Handling Procedure	Drugs	1,193	26%
21 CFR 211.194Complete test data included in records	Drugs	1,184	27%
21 CFR 820.72Calibration, Inspection, etc. Procedures Lack of or Inadequ	Devices	1,084	20%
21 CFR 211.110Control procedures to monitor and validate performance	Drugs	1,066	30%
21 CFR 211.180Items to cover on annual reviews	Drugs	1,049	24%
21 CFR 803.50Individual Report of Malfunction	Devices	990	27%
21 CFR 820.181DMR - not or inadequately maintained	Devices	890	27%
21 CFR 606.160Concurrent documentation	Biologics	790	3%
21 CFR 211.63Equipment Design, Size and Location	Drugs	698	36%
21 CFR 211.80Procedures To Be in Writing	Drugs	658	25%
21 CFR 812.140Investigator's subject records inadequate	Devices	646	16%
21 CFR 211.186Written procedures followed	Drugs	581	20%
21 CFR 211.142Storage under appropriate conditions	Drugs	554	16%
21 CFR 314.80Failure to develop written procedures	Drugs	527	8%
21 CFR 820.250Sampling plans	Devices	504	26%
21 CFR 211.170Annual visual exams of drug products	Drugs	472	28%
21 CFR 211.125Strict control not exercised over labeling issued	Drugs	467	22%
21 CFR 820.120Lack of or inadequate procedures for labeling	Devices	460	23%
21 CFR 211.56Sanitation--buildings not clean, free of infestation	Drugs	440	31%
21 CFR 812.110Investigator non-compliance with agreement/plan/regulations	Devices	361	11%
21 CFR 211.130Procedures are written, and followed	Drugs	349	28%
21 CFR 211.137Expiration date lacking	Drugs	342	41%
21 CFR 820.200Servicing - Lack of or inadequate procedures	Devices	327	18%
21 CFR 211.58Buildings not maintained in good state of repair	Drugs	320	27%
21 CFR 812.100Investigator non-compliance with agreement/plan/regulations	Devices	320	8%
21 CFR 806.10Report of risk to health	Devices	317	32%
21 CFR 211.182Written records kept in individual logs	Drugs	313	24%
21 CFR 211.28Clothing appropriate for duties performed	Drugs	310	57%
21 CFR 606.60Equipment observed, standardized, calibrated	Biologics	307	2%
21 CFR 211.122Written procedures describing in detail	Drugs	303	16%
21 CFR 211.150Recall facilitation	Drugs	268	26%
21 CFR 211.46Equipment for Environmental Control	Drugs	222	32%
21 CFR 314.81Failure to meet specifications	Drugs	221	17%
21 CFR 606.171Biological product deviation report	Biologics	215	2%
21 CFR 211.111Establishment of time limitations	Drugs	210	35%
21 CFR 806.20Justification for not reporting	Devices	189	19%
21 CFR 211.103Actual vs. theoretical yields not determined	Drugs	167	23%
21 CFR 211.167Sterility/pyrogen-free testing	Drugs	165	76%
21 CFR 820.150Lack of or inadequate procedures for storage.	Devices	160	18%
21 CFR 211.101Component addition checked by 2nd person	Drugs	154	28%
21 CFR 606.65Following manufacturer's instructions	Biologics	146	3%
21 CFR 606.40Provide space for examination	Biologics	142	2%
21 CFR 211.105Distinctive ID or code not recorded in batch record	Drugs	133	28%
21 CFR 820.160Lack of or inadequate procedures for distribution	Devices	130	29%
21 CFR 801.20Label to bear a unique device identifier	Devices	126	17%
21 CFR 606.170Adverse Reaction - Investigations	Biologics	124	3%
21 CFR 820.60Identification procedures, Lack of or inadequate procedures	Devices	120	26%
21 CFR 820.180Availability	Devices	118	19%
21 CFR 812.40Sponsors' general responsibilities	Devices	117	22%
21 CFR 830.300Devices subject to device identification GUDID data submission requirements.	Devices	112	21%
21 CFR 211.184Individual inventory record	Drugs	105	28%
21 CFR 211.204Returned drug procedures in writing and followed	Drugs	104	19%
21 CFR 630.40Notification	Biologics	104	7%
21 CFR 820.86Acceptance status	Devices	102	19%
21 CFR 212.20Written QA procedures established, followed	Drugs	101	16%
21 CFR 211.115Reprocessing procedures not written or followed	Drugs	100	31%
21 CFR 606.20Qualifications of responsible personnel	Biologics	97	9%
21 CFR 211.94Containers & Closures Clean, Sterilized, Pyrogen-free	Drugs	96	60%
21 CFR 812.150Investigator report of unanticipated adverse effects	Devices	89	24%
21 CFR 600.14Who must report - manufacturer	Biologics	88	2%
21 CFR 640.3Donor suitability procedures not followed	Biologics	84	10%
21 CFR 212.30Orderly handling, prevention of mix-ups, prevention of contamination	Drugs	80	13%
21 CFR 630.10Proof Of Identity	Biologics	78	0%
21 CFR 812.43No investigator agreement	Devices	77	42%
21 CFR 211.134Correct labels during finishing operations	Drugs	74	33%
21 CFR 211.196Distribution Record Requirements	Drugs	72	43%
21 CFR 211.82Quarantine Storage of Components	Drugs	65	13%
21 CFR 211.52Washing and toilet facilities are deficient	Drugs	63	27%
21 CFR 606.151Procedures to maintain records of emergency transfusions	Biologics	61	0%
21 CFR 211.87Retest of approved components/containers/closures	Drugs	60	31%
21 CFR 211.48Plumbing System Defects	Drugs	58	38%
21 CFR 803.56Submission of Supplement to Individual Report Within One Month	Devices	58	31%
21 CFR 820.170Lack of or inadequate instructions	Devices	58	19%
21 CFR 640.4Arm preparation	Biologics	58	3%
21 CFR 211.65Equipment construction - reactive surfaces	Drugs	55	30%
21 CFR 803.18Adverse events--all info not in file	Devices	55	20%
21 CFR 820.186QSR	Devices	53	25%
21 CFR 820.140Lack of or inadequate procedures for handling	Devices	49	35%
21 CFR 640.25Storage temps./agitation	Biologics	49	10%
21 CFR 606.140Establishment of spec., standards, and test procedures	Biologics	45	9%
21 CFR 211.89Quarantine of Rejected Components et. al.	Drugs	43	12%
21 CFR 212.60Analytical methods	Drugs	42	12%
21 CFR 212.50Adequate controls (general)	Drugs	41	15%
21 CFR 600.10Personnel capabilities	Biologics	41	5%
21 CFR 361.1Numerical votes not in the minutes of any RDRC meetings	Drugs	40	0%
21 CFR 812.46Sponsor securing investigator compliance	Devices	33	36%
21 CFR 803.40Report of death, injury	Devices	31	29%
21 CFR 830.310GUDID Information required for unique device identification.	Devices	29	17%
21 CFR 803.52Patient Name or Other Identifier	Devices	29	41%
21 CFR 600.12Maintenance - tracing	Biologics	29	7%
21 CFR 310.305Failure to submit ADE report	Drugs	28	30%
21 CFR 820.130Packaging	Devices	28	46%
21 CFR 606.121Labeling of blood products unsuitable for transfusion	Biologics	28	7%
21 CFR 640.64Prevention of contamination	Biologics	26	0%
21 CFR 803.30Report of Serious Injury Within 10 Days	Devices	21	29%
21 CFR 211.44Adequate lighting not provided	Drugs	19	21%
21 CFR 212.71Correction of problems	Drugs	19	0%
21 CFR 812.25Sponsor's lack of written monitoring procedures	Devices	19	42%
21 CFR 212.40Use of reliable suppliers	Drugs	17	19%
21 CFR 640.21Informed consent	Biologics	17	0%
21 CFR 600.80Reporting Requirements - 15-day alert	Biologics	17	6%
21 CFR 211.176Failing to test for penicillin cross-contamination	Drugs	16	43%
21 CFR 630.30Unsuitable donation - release	Biologics	16	0%
21 CFR 812.2Abbreviated requirements / non-significant risk study	Devices	15	40%
21 CFR 640.31Donor eligibility	Biologics	15	7%
21 CFR 640.61Explanation of hazards	Biologics	15	7%
21 CFR 640.63Determining donor suitability	Biologics	15	20%
21 CFR 211.34Consultant Records	Drugs	14	23%
21 CFR 820.35Records for complaints involving failure to meet specifications not maintained	Devices	14	29%
21 CFR 600.15Blood & Blood Components	Biologics	13	0%
21 CFR 610.41Donor Deferral	Biologics	13	23%
21 CFR 640.11General requirements - storage	Biologics	13	8%
21 CFR 640.65Physician review of four month sample	Biologics	12	8%
21 CFR 630.5CPR certification	Biologics	11	0%
21 CFR 212.10Personnel not qualified	Drugs	10	0%
21 CFR 812.7Promotion or test marketing	Devices	10	80%
21 CFR 610.47Notification of transfusion recipients	Biologics	10	10%
21 CFR 211.208No records maintained	Drugs	9	43%
21 CFR 211.86Rotation of components/containers/closures	Drugs	8	43%
21 CFR 801.40Form of a unique device identifier	Devices	8	0%
21 CFR 812.42Sponsor began study before IRB/FDA approval	Devices	8	75%
21 CFR 212.70Conform to specs prior to release	Drugs	6	17%
21 CFR 807.20Devices not listed	Devices	6	33%
21 CFR 820.65Traceability Lack of or inadequate {see also 820.120(e)}	Devices	6	17%
21 CFR 821.25Quality assurance procedures: 6-month & annual audits	Devices	6	50%
21 CFR 610.40Labeling of reactive units, units from deferred donors	Biologics	6	17%
21 CFR 211.50Sewage and refuse disposal in safe manner	Drugs	5	20%
21 CFR 803.53Failure to Submit 5 Day Report	Devices	5	40%
21 CFR 812.35No approval for changes requiring prior approval	Devices	5	60%
21 CFR 812.36No IRB approval for treatment use	Devices	5	60%
21 CFR 812.5Label does not contain required information	Devices	5	60%
21 CFR 812.66No IRB notification of significant risk determination	Devices	5	40%
21 CFR 601.12Moderate changes to an approved application	Biologics	5	20%
21 CFR 606.165Distribution and receipt - recalls	Biologics	5	0%
21 CFR 610.46Quarantine and notification	Biologics	5	20%
21 CFR 640.2Blood not stored between 1-6 deg / shipped 1-10 deg	Biologics	5	0%
21 CFR 640.72Donor reaction	Biologics	5	0%

Citations are the regulation references FDA posts for inspections (Form 483 observations), counted once per inspection. Paragraphs fold into their section. Text comes from eCFR, the official online CFR. FDA Data Dashboard inspection citations and eCFR