Regulations FDA cites in inspections
What each 21 CFR section requires, in plain English, how investigators word it, and the Form 483s where they cited it. Only sections FDA has cited in the inspections we track are listed.
Most cited in drug 483s since 2023
The share of drug-manufacturing Form 483s dated 2023 or later that cite each section at least once.
Drug-manufacturing Form 483s dated 1 January 2023 or later. A 483 counts once per section, however many observations cite it. Updated daily.
Every cited section, by part
Filter by section number or topic, or pick a part. Each section links to what it requires and the 483s that cite it.
Drugs
Drug CGMP, PET drugs and new drug applications.
Current Good Manufacturing Practice for Finished Pharmaceuticals
Organization and Personnel
Buildings and Facilities
Equipment
Control of Components and Drug Product Containers and Closures
- 211.80General requirements
- 211.82Receipt and storage of untested components, drug product containers, and closures
- 211.84Testing and approval or rejection of components, drug product containers, and closures
- 211.86Use of approved components, drug product containers, and closures
- 211.87Retesting of approved components, drug product containers, and closures
- 211.89Rejected components, drug product containers, and closures
- 211.94Drug product containers and closures
Production and Process Controls
Packaging and Labeling Control
Holding and Distribution
Laboratory Controls
Records and Reports
- 211.180General requirements
- 211.182Equipment cleaning and use log
- 211.184Component, drug product container, closure, and labeling records
- 211.186Master production and control records
- 211.188Batch production and control records
- 211.192Production record review
- 211.194Laboratory records
- 211.196Distribution records
- 211.198Complaint files
Returned and Salvaged Drug Products
Current Good Manufacturing Practice for Positron Emission Tomography Drugs
Quality Assurance
Facilities and Equipment
Production and Process Controls
New Drugs
Applications for FDA Approval to Market a New Drug
Medical devices
Quality system, complaint and MDR reporting, corrections and UDI.
Medical Device Reporting
General Provisions
Generally Applicable Requirements for Individual Adverse Event Reports
User Facility Reporting Requirements
Manufacturer Reporting Requirements
- 803.50If I am a manufacturer, what reporting requirements apply to me?
- 803.52If I am a manufacturer, what information must I submit in my individual adverse event reports?
- 803.56If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?
Medical Devices; Reports of Corrections and Removals
Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
Quality System Regulation
Most device 483s cite the Quality System Regulation in force before February 2, 2026, when the QMSR replaced it. Those sections are marked Former.
General Provisions
Quality System Requirements
Design Controls
Document Controls
Purchasing Controls
Identification and Traceability
Production and Process Controls
Acceptance Activities
Nonconforming Product
Corrective and Preventive Action
Labeling and Packaging Control
Handling, Storage, Distribution, and Installation
Records
Servicing
Statistical Techniques
Unique Device Identification
Biologics, blood & tissue
Biological products, blood establishments and HCT/Ps.
Biological Products: General
Establishment Standards
Reporting of Adverse Experiences
Licensing
Current Good Manufacturing Practice for Blood and Blood Components
Organization and Personnel
Production and Process Controls
Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
Additional Standards for Human Blood and Blood Products
Whole Blood
Source Plasma
Human Cells, Tissues, and Cellular and Tissue-Based Products
Donor Eligibility
- 1271.47What procedures must I establish and maintain?
- 1271.50How do I determine whether a donor is eligible?
- 1271.55What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?
- 1271.60What quarantine and other requirements apply before the donor-eligibility determination is complete?
- 1271.65How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?
- 1271.75How do I screen a donor?
- 1271.80What are the general requirements for donor testing?
- 1271.85What donor testing is required for different types of cells and tissues?
Current Good Tissue Practice
- 1271.150Current good tissue practice requirements
- 1271.160Establishment and maintenance of a quality program
- 1271.170Personnel
- 1271.180Procedures
- 1271.190Facilities
- 1271.195Environmental control and monitoring
- 1271.200Equipment
- 1271.210Supplies and reagents
- 1271.220Processing and process controls
- 1271.230Process validation
- 1271.250Labeling controls
- 1271.260Storage
- 1271.265Receipt, predistribution shipment, and distribution of an HCT/P
- 1271.270Records
- 1271.290Tracking
- 1271.320Complaint file
Additional Requirements for Establishments Described in § 1271.10
Food & dietary supplements
Food CGMP and preventive controls, seafood and juice HACCP, shell eggs, supplements.
Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications
Emergency Permit Control
Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food
General Provisions
Buildings and Facilities
Equipment
Production and Process Controls
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
Physical Plant and Grounds
Equipment and Utensils
Requirement to Establish a Production and Process Control System
Production and Process Control System: Requirements for Quality Control
- 111.103What are the requirements under this subpart F for written procedures?
- 111.105What must quality control personnel do?
- 111.113What quality control operations are required for a material review and disposition decision?
- 111.123What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?
Production and Process Control System: Requirements for the Master Manufacturing Record
Production and Process Control System: Requirements for the Batch Production Record
Production and Process Control System: Requirements for Laboratory Operations
Holding and Distributing
Acidified Foods
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
Current Good Manufacturing Practice
Hazard Analysis and Risk-Based Preventive Controls
Production, Storage, and Transportation of Shell Eggs
- 118.4Salmonella Enteritidis (SE) prevention measures
- 118.5Environmental testing for Salmonella Enteritidis (SE)
- 118.7Sampling methodology for Salmonella Enteritidis (SE)
- 118.8Testing methodology for Salmonella Enteritidis (SE)
- 118.9Administration of the Salmonella Enteritidis (SE) prevention plan
- 118.10Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan
Clinical research & GLP
Informed consent, IRBs, nonclinical labs, IND and device studies.
Protection of Human Subjects
Institutional Review Boards
General Provisions
IRB Functions and Operations
Records and Reports
Good Laboratory Practice for Nonclinical Laboratory Studies
Organization and Personnel
Testing Facilities Operation
Protocol for and Conduct of a Nonclinical Laboratory Study
Records and Reports
Investigational New Drug Application
Investigational New Drug Application (IND)
Responsibilities of Sponsors and Investigators
- 312.50General responsibilities of sponsors
- 312.53Selecting investigators and monitors
- 312.56Review of ongoing investigations
- 312.57Recordkeeping and record retention
- 312.60General responsibilities of investigators
- 312.62Investigator recordkeeping and record retention
- 312.64Investigator reports
- 312.66Assurance of IRB review
Bioavailability and Bioequivalence Requirements
Animal food & drugs
Animal food preventive controls, medicated feeds and veterinary drugs.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
Current Good Manufacturing Practice
Hazard Analysis and Risk-Based Preventive Controls
New Animal Drug Applications
Extralabel Drug Use in Animals
Labeling
Drug and device labeling requirements.
Records & general
Electronic records and signatures, and other agency-wide rules.
Electronic Records; Electronic Signatures
Electronic Records
Electronic Signatures
Electronic products & tobacco
Radiation-emitting products and tobacco.
Records and Reports
Performance Standards for Electronic Products: General
Performance Standards for Light-Emitting Products
Questions
Which regulations does FDA cite most in Form 483s?
In drug-manufacturing 483s from 2023 onward, the most cited sections are 21 CFR 211.192 (Production record review), 21 CFR 211.22 (Responsibilities of quality control unit), 21 CFR 211.67 (Equipment cleaning and maintenance). 211.192 appears in about 42% of them.
What is 21 CFR Part 211?
Part 211 is FDA's current good manufacturing practice (CGMP) rule for finished pharmaceuticals. It covers the quality control unit, buildings, equipment, production and process controls, laboratory controls, records and complaint handling.
Does a Form 483 always cite a regulation?
Not always. Many 483 observations quote or paraphrase the requirement without printing the section number. Where FDA did not print it, a section is only linked here after a second check confirms it.
Is a 483 citation a finding of violation?
No. A Form 483 lists an investigator's observations. FDA decides afterwards whether they are violations, for example in a warning letter.