Most Common FDA Form 483 Observations in Equipment Qualification (2022–2025)
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Equipment qualification remains one of the most scrutinized areas during FDA inspections—and for good reason. Deficiencies here can lead to contamination, data integrity issues, and batch rejections. This blog highlights real FDA Form 483 citations from 2022 to 2024 related to equipment qualification, complete with investigator names and company details. Plus, we offer actionable Corrective and Preventive Actions (CAPA) to help you stay ahead of warning letters.
Why It Matters
When equipment isn't properly qualified, everything that follows is at risk: product quality, patient safety, and regulatory standing. Analyzing real FDA citations helps pharma companies:
- Uncover systemic risks
- Avoid costly regulatory escalations
- Strengthen internal qualification procedures
Most Frequent FDA 483 Observations in Equipment Qualification
1. Aseptic Processing Deficiencies in Equipment Maintenance
Company Issued: Empower Pharmacy
Date Issued: August 28, 2024
Investigator: Dogbeda F Mackenzie
Observation:
Scratches observed inside ISO-5 hoods compromised the cleanability of critical aseptic surfaces.
Corrective Action:
Replace or repair all scratched ISO-5 surfaces and requalify affected equipment.
Preventive Action:
Enforce strict pre-qualification inspections of all aseptic equipment for integrity and cleanability.
2. Lack of Authorization Controls on Computerized Systems
Company Issued: Jiangsu Hengrui Pharmaceuticals Co., Ltd
Date Issued: January 16, 2024
Investigators: Arsen Karapetyan, Qiao Y Bobo
Observation:
Critical GMP equipment lacked evidence of proper qualification; system changes were unauthorized.
Corrective Action:
Immediately qualify all GMP equipment using a risk-based approach.
Preventive Action:
Establish a centralized Equipment Qualification (EQ) program covering IQ, OQ, and PQ with audit trails.
3. Lack of Documented Quality Control Procedures
Company Issued: Sun Pharmaceutical Industries Limited
Date Issued: December 15, 2023
Investigator: Pratik S Upadhyay
Observation:
QC incubators had no usage logbooks, creating gaps in equipment tracking.
Corrective Action:
Implement mandatory logbooks for all critical equipment in QC and manufacturing.
Preventive Action:
Conduct periodic reviews of logbook entries and reinforce SOP compliance through training.
4. Absence of Written Production and Process Controls
Company Issued: Fagron Compounding Services
Date Issued: March 24, 2022
Investigators: Anthony J Ladner, Alan M Barker
Observation:
Equipment was relocated without requalification or updated process control documentation.
Corrective Action:
Create SOPs for equipment requalification during relocations; requalify all affected units.
Preventive Action:
Incorporate requalification triggers into existing change control processes.
5. Inadequate Cleaning Intervals for Equipment Maintenance
Company Issued: Actavis Laboratories FL, Inc.
Date Issued: July 19, 2022
Investigators: Jennifer L Huntington, Heana Barreto-Pettit, Chiaochun J Wang, Fabian N Chaparro-Rodriguez
Observation:
Failure to follow manufacturer-recommended lens cleaning led to dirty inspection equipment.
Corrective Action:
Update SOPs to reflect manufacturer cleaning instructions and retrain teams.
Preventive Action:
Schedule routine SOP reviews and align cleaning intervals with supplier specifications.
Eliminate Qualification Gaps with Leucine MES
Leucine’s Batch Execution & MES platform gives QA leaders real-time control over qualification-linked workflows:
- Auto-enforce EQ protocols (IQ/OQ/PQ) before batch execution
- Capture deviations and documentation in one interface
- Ensure traceability and compliance with 21 CFR Part 11, EU GMP, WHO GMP
- Eliminate human error with digital SOP checklists and qualification triggers
No more unqualified equipment use. Just compliant, audit-ready execution.
Stay Ahead with FDA Tracker
FDA Tracker is your compliance command center:
- View all recent FDA 483s related to equipment qualification
- Analyze by investigator, company, or subsystem
- Access CAPA templates and trend reports
- Stay informed on emerging risks before your next inspection
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