FDA INSPECTION INTELLIGENCE

FDA 483 Observation Explorer

What does FDA actually write up? These are the real observation types cited on Form FDA 483 across the GxP program areas — drugs, devices, food, biologics and veterinary — grouped by type, with counts by program area and fiscal year. Every line is FDA's own citation text.

131,470 citations · 1,369 observation types

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The 300 most-cited types, ranked. Search or filter by how often FDA writes the observation and across how many firms.

300 observation types in library

#1Develop FSVP4,9203,609

#2Lack of or inadequate procedures2,3701,998

#3Lack of or inadequate complaint procedures1,7721,592

#4Sanitation monitoring1,6621,371

#5Personnel1,6581,460

#6Pest control1,5351,339

#7Sanitary operations - Plant maintenance1,4861,301

#8Procedures not in writing, fully followed1,4761,241

#9Manufacturing, processing, packing, holding - Controls1,3941,243

#10HACCP plan implementation1,155920

#11Equipment and utensils - Design and maintenance1,1221,023

#12FD-1572, protocol compliance1,015970

#13Investigations of discrepancies, failures969812

#14Plant construction and design940857

#15Purchasing controls, Lack of or inadequate procedures933818

#16Documentation900795

#17Food safety hazards875798

#18Scientifically sound laboratory controls869744

#19Lack of Written MDR Procedures858804

#20Sanitary operations - Plant sanitation841792

#21Nonconforming product, Lack of or inadequate procedures838769

#22Absence of Written Procedures829707

#23Critical control points819757

#24Record keeping797749

#25Evaluation - performance, risk787714

#26Lack of effective pest exclusion780745

#27Sanitary facilities and controls780734

#28Lack of or inadequate process validation772673

#29Importer verification700525

#30Specifications - identity, purity, strength, composition687563

#31Sanitation of food-contact surfaces - Frequency653597

#32Critical limits650570

#33Hazard analysis - Identification of hazard637585

#34Supplier verification - establish written procedures623564

#35No HACCP plan621573

#36Hazard analysis written599554

#37Hazard analysis biological, chemical, physical592523

#38Approved supplier procedures - importer established586543

#39Cleaning / Sanitizing / Maintenance572506

#40ELDU - producer causes Illegal drug residue567539

#41Process filing560480

#42Case history records- inadequate or inadequate556540

#43Monitoring - adequacy535477

#44Verification activity before import, periodically534483

#45Screening523508

#46Hazard Analysis - Identification of Hazard520470

#47Quality audits - Lack of or inadequate procedures515473

#48Storage and Distribution513479

#49Corrective action plan495435

#50Sanitation Records490450

#51Computer control of master formula records488430

#52Design changes - Lack of or Inadequate Procedures466418

#53Food safety plan447401

#54Equipment Design, Size and Location443395

#55Floors, walls and ceilings443425

#56Written procedures not established/followed443398

#57Signed and dated434399

#58Written procedures - quality control operations434371

#59Testing and release for distribution430388

#60Supplier approval - document427401

#61Procedures for sterile drug products415330

#62Component - verify identity, dietary ingredient404337

#63Buildings/sanitary386374

#64Training - Lack of or inadequate procedures383360

#65Lack of written stability program373339

#66Calibration/Inspection/Checking not done371337

#67DMR - not or inadequately maintained371339

#68Batch record - complete367288

#69Control procedures to monitor and validate performance357328

#70Specifications-component purity, strength, composition355296

#71Manufacturing conditions350338

#72Calibration, Inspection, etc. Procedures Lack of or Inadequ348315

#73Specifications - component identity348291

#74Component - qualify supplier343282

#75Lack of or inadequate DHR procedures343317

#76Verification - record review - frequency340304

#77Design control - no procedures339316

#78Sanitation of non-food-contact surfaces - Manner and frequency335308

#79Verification activity assurance329313

#80Procedures not adequately established or maintained326307

#81Specifications - finished dietary supplement326321

#82Plant operations - Precautions325309

#83Cleaning and sanitizing operations322315

#84Lack of or inadequate procedures - Acceptance activities322297

#85Specifications met - verify; finished batch321259

#86Specifications - components318311

#87Reasonable precautions317304

#88Grounds316289

#89Verification procedures - adequacy313282

#90Environmental Monitoring System311264

#91Prevention of contamination310251

#92Written procedures - holding307283

#93Harborage areas306291

#94Design Validation - Risk analysis not performed/inadequate304280

#95Management review - Lack of or inadequate procedures303286

#96Lack of or inadequate final acceptance procedures301286

#97Written procedures - product complaint300270

#98Cleaning and sanitizing substances - Safe and adequate297282

#99DHR - not or inadequately maintained297281

#100Master manufacturing record - each batch295266

#101Process control procedures, Lack of or inadequate procedures294276

#102Investigation of device failures289270

#103Verification activity frequency289274

#104Sanitation preventive controls - Appropriate (Adequate)286268

#105Complaints284267

#106Document review entity's hazard analysis283274

#107Establish, maintain and follow manufacturing SOPs279236

#108Equipment, containers, utensils275269

#109HACCP training or qualification273254

#110Code - required elements271259

#111Training of employees and records269250

#112Training--operations, GMPs, written procedures266244

#113Qualifications of individuals263249

#114Failure to wear261249

#115Buildings/good repair259250

#116Not washed/sanitized when appropriate259248

#117Environmental control Lack of or inadequate procedures258230

#118Scheduled process257239

#119Design history file256238

#120DHR content256243

#121Risk factors, clinical evidence256198

#122Maintenance of processing and production records253224

#123Individual Report of Malfunction247223

#124Lack of or inadequate receiving acceptance procedures243230

#125Failure to clean - general242232

#126Prepared for each batch, include complete information242225

#127Lack of quality control unit239224

#128Validation lacking for sterile drug products239207

#129Process preventive controls - Implement232210

#130Test methods232218

#131Design validation- Lack of or inadequate procedures231218

#132Specifications - labels, packaging227195

#133Process control - Foreign objects225216

#134Reserve sample - collect, hold220208

#135SOPs not followed / documented220212

#136Process preventive controls - Appropriate (Adequate)219207

#137Cleaning System216184

#138Corrective action per predetermined plan216185

#139Calibration - adequacy215188

#140Running water at suitable temperature215208

#141Sanitation preventive controls - Implement215189

#142Written record of investigation incomplete212206

#143Training records211201

#144Toxic chemicals - Identified, held, stored208197

#145Safety lighting and glass207206

#146Materials and workmanship206202

#147Written procedures - returned dietary supplement206198

#148Batch record - every batch205183

#149Registration205194

#150Process adherence204195

#151Storage204200

#152Hazard analysis200177

#153Procedures for non-sterile drug products200185

#154As source of contamination199193

#155Training , Education , Experience overall199188

#156Following/documenting laboratory controls197186

#157Drip and condensate196193

#158Maintenance of equip., utensils, and finished food packaging196191

#159Scheduled process establishment196180

#160Investigator non-compliance with agreement/plan/regulations193189

#161Quality Audit/Reaudit - conducted193185

#162Sanitation monitoring documentation193175

#163Batch record - required information192188

#164Approved school191188

#165Sufficient space190183

#166Management review - defined interval, sufficient frequency188174

#167Complete test data included in records187173

#168Items to cover on annual reviews187174

#169Preventive Controls186144

#170Complaint Handling Procedure185176

#171Testing, screening, donor eligibility procedures183155

#172Buildings not maintained in good state of repair182170

#173Evaluation of suppliers, contractors, etc., requirements179171

#174Drug inventory (control of drugs on premises)178172

#175Master manufacturing record - record requirements177173

#176Software validation for automated processes177163

#177Very small importer assurances, supplier176160

#178Identification - entry173160

#179Record - translate to English173160

#180Hazard Analysis172153

#181Reports of Analysis (Components)171152

#182Sanitation Controls Verif Procedures: Establish Implement171156

#183Storage under appropriate conditions171159

#184Master manufacturing record - unique formulation168160

#185Records - content168160

#186Report of Death or Serious Injury164155

#187Written program not followed163149

#188Quality control - quality, dietary supplement159133

#189Lack of procedures, or not maintained157152

#190Lack/Inad procedure-Monitoring/Control of Validated Proces156143

#191Storage of personal items156149

#192Nonconforming product control155150

#193Storage requirements155153

#194Preventive Controls - Identify154145

#195Written procedures - holding; distributing154145

#196Allergen preventive controls - Implement153140

#197GMP Training Frequency152149

#198Microbiological testing152142

#199Precautions against contamination--micro, foreign substances150148

#200Verification procedures - none/frequency148138

#201Seams on food contact surfaces147145

#202Food contact surface sanitary inspection and maintenance145127

#203Prescribed directions - not followed145134

#204Expiration date lacking144138

#205Appropriate quality control operations143141

#206No written record of investigation143137

#207Supply-chain program - Assurance (Adequate)142135

#208Establish reliability of supplier's C of A141136

#209Individual identity of animal(s)141138

#210Quality Audits - defined intervals141134

#211Sanitation--buildings not clean, free of infestation141136

#212Batch production and Batch Control Record Requirements140132

#213Determination based on screening and testing140120

#214Sanitation Controls Procedures140133

#215Sanitation Controls Monitoring Proced: Establish Implement139127

#216Acceptable supplier records, inadequate records138132

#217Verification activity - appropriate135129

#218Accountability records134132

#219Master manufacturing record - prepared134133

#220Product rework procedures, Lack of or inadequate procedures134130

#221Allergen preventive controls - Appropriate (Adequate)133127

#222Hazard analysis - Conducted133126

#223Records of complaint investigation132128

#224Maintenance schedule, Lack of or inadequate schedule131124

#225Suitable locations131127

#226Tests, examinations - scientifically valid131117

#227Valid stability test methods131124

#228Process Controls Monitoring Procedures: Establish Implement129120

#229Q.C. instrument accuracy, maintenance129129

#230Effective use of hair restraint128125

#231Introduction/delivery into IS - illegal drug residue128125

#232Lack of or inadequate procedures for labeling128122

#233Records reviewed annually128121

#234Specifications - contamination limits128118

#235Identity Testing of Each Component127120

#236Instruments and Controls127122

#237Strict control not exercised over labeling issued127121

#238Allergen Controls Monitoring Proced: Establish Implement125113

#239Hand cleaning and sanitizing preparations125122

#240Procedures to be written and followed125120

#241Annual visual exams of drug products124121

#242Audit - food safety regulation, plan123109

#243Drugs prohibited for extralabel use in food-producing animal(s)123119

#244Unsecured jewelry123120

#245Label to bear a unique device identifier122121

#246Personal food/drink/tobacco122122

#247Specifications - contamination limits122109

#248Production processes121116

#249Records - returned dietary supplement: written procedures120111

#250HACCP plan not implemented11999

#251Raw materials - Allergen identification119112

#252Quality control - processes, specifications, written procedures118107

#253Raw materials, packaging, finished product118106

#254Supply-Chain Program Establish and Implement118109

#255Design verification - Lack of or inadequate procedures116111

#256Metal / extraneous materials116113

#257Quality control procedures116109

#258Storage/transportation of finished goods (contamination)115114

#259Servicing - Lack of or inadequate procedures114109

#260Documented evaluation113109

#261Recall procedures113102

#262Expired drugs administered112110

#263Prevention of the spread of communicable diseases11295

#264Quality System Procedures112110

#265Safe and adequate for use112112

#266Work-in-progress112108

#267Lab controls established, including changes111103

#268Procedure Deviations Recorded and Justified111110

#269Records review prior to shipment for slaughter111111

#270Calibration - at intervals, written program, remedial action110105

#271Onsite audit110102

#272Authority lacking to review records, investigate errors109103

#273Devices subject to device identification GUDID data submission requirements.109109

#274Hygienic practices10899

#275Sampling plans108101

#276Written procedures - product complaint; review, investigate108103

#277Prescribed ELDU - vet causes an illegal drug residue106104

#278Quality control unit review of records106100

#279Supply-chain program - Implement10694

#280Written procedures - establish; returned dietary supplements106106

#281Complete Test Data10597

#282Appropriate tests, examinations; certificate of analysis10493

#283Quality audits - auditor independence10499

#284Written records kept in individual logs104103

#285Coding - required elements103103

#286HACCP plan location10399

#287Supplier oversight103102

#288Failure to develop written procedures10295

#289Extent of discrepancy, failure investigations10197

#290Process preventive controls - Identify (Written)10197

#291Required records10080

#292Procedures To Be in Writing9996

#293Component identity verification9895

#294Production, process controls - implement9886

#295Design review - Lack of or inadequate procedures9795

#296Glove condition9797

#297Hand drying9797

#298Lack of System for Event Evaluations9794

#299pH testing9796

COMPLETE INDEX — ALL 300 OBSERVATION TYPE