QMS Hub
chevron left
FDA Observations CAPA

FDA Observations CAPA

September 24, 2024
8
 mins read

1. Failure to Review Discrepancies Leads to Repeated Production Issues

Possible Root Cause:
Inadequate investigations, ineffective CAPA system, insufficient filling line monitoring, weak stability testing.

Corrective Action:
Revise investigation procedures, enhance CAPA system, implement stringent filling line controls, develop robust stability testing.

Preventive Action:
Retrain staff, install monitoring systems, conduct risk assessments, establish routine review meetings.

Reference FDA 483:
Company Name: Eugia Pharma Specialities Limited
Issue Date: 02-Feb-24
Inspection Dates: 22 Jan 2024 to 02 Feb 2024
Investigators: Justin A Boyd, Eileen A Liu, Anastasia M Shields

2. Systemic Weaknesses in Handling Discrepancies Risk Product Quality

Possible Root Cause:
Weak investigation process, inadequate lot connections, delayed completions.

Corrective Action:
Revamp investigation processes, extend analyses to impacted batches, implement training for investigative rigor.

Preventive Action:
Introduce tracking for investigation timelines, establish a continuous improvement program to identify trends and mitigate recurrences.

Reference FDA 483:
Company Name: Stokes Healthcare Inc. dba Epicur Pharma
Issue Date: 25-Oct-23
Inspection Dates: 26 Sep 2023 to 25 Oct 2023
Investigators: Christina K Theodorou, Yoriann Rodriguez

3. SOPs Allow Bypassing Thorough Investigations, Risking Sterility Assurance

Possible Root Cause:
Lax procedures, inadequate investigations, insufficient sterility controls, systemic aseptic issues.

Corrective Action:
Revise SOPs, train staff, enhance environmental monitoring, evaluate sporicidal disinfectants' effectiveness.

Preventive Action:
Routine CAPA reassessment, increased quality oversight, robust validation, comprehensive environmental monitoring.

Reference FDA 483:
Company Name: SCA Pharmaceuticals, LLC
Issue Date: 20-Oct-23
Inspection Dates: 18 Sep 2023 to 20 Oct 2023
Investigators: Jonah S Ufferfilge, John P Mistell

4. Deficient Investigation Processes Risk Recurring Quality Issues

Possible Root Cause:
Poorly defined procedures, inadequate training, weak documentation, limited investigation scope.

Corrective Action:
Develop comprehensive SOPs, conduct training, enhance record-keeping, expand investigation scope.

Preventive Action:
Regular training programs, periodic senior reviews, digital tracking, risk-based investigation approach.

Reference FDA 483:
Company Name: Sichuan Deebio Pharmaceutical Co. Ltd.
Issue Date: 08-Sep-23
Inspection Dates: 04 Sep 2023 to 08 Sep 2023
Investigators: Arsen Karapetyan, Anders W Evenson

5. High Mold Recoveries Reveal Inadequate Environmental Controls

Possible Root Cause:
Inadequate monitoring, lax action limits, ineffective CAPA measures.

Corrective Action:
Enforce stricter monitoring, implement targeted cleaning, thoroughly investigate microbial excursions.

Preventive Action:
Review and improve monitoring strategies, enhance staff training, regularly update CAPA procedures.

Reference FDA 483:
Company Name: Alvotech Hf
Issue Date: 22-Mar-22
Inspection Dates: 10 Mar 2022 to 17 Mar 2022
Investigators: Madushini Dharmasena, PhD, Senior Pharmacist

6. Management Awareness of Safety Issues Reveals Quality Failures

Possible Root Cause:
Ineffective oversight, poor risk management, weak CAPA processes, inadequate communication.

Corrective Action:
Review management and CAPA processes, enhance training, develop robust risk management, reevaluate product designs.

Preventive Action:
Regular management reviews, routine CAPA and risk audits, improved training programs, better communication channels.

Reference FDA 483:
Company Name: Philips Respironics, Inc.
Issue Date: 09-Nov-21
Inspection Dates: 26 Aug 2021 to 09 Nov 2021
Investigators: Katelyn A Staub-Zamperini

7. Systemic Issues in Quality Control Require Comprehensive Overhaul

Possible Root Cause:
Lack of procedures, ineffective investigations, delayed reporting, insufficient documentation, weak CAPA implementation.

Corrective Action:
Implement comprehensive written procedures, conduct thorough investigations, update reporting systems, review supplier qualifications, enhance CAPA.

Preventive Action:
Regular training, periodic quality reviews, risk management approach, routine audits of processes.

Reference FDA 483:
Company Name: Empower Clinic Services LLC dba Empower Pharmacy
Issue Date: 05-Aug-22
Inspection Dates: 18 Jul 2022 to 05 Aug 2022
Investigators: Margaret M Annes, Suzanne N Vallez

LEUCINE 10X QMS
Experience seamless Cleaning Validation
Automate your cleaning validation calculations to reduce errors, achieve compliance, and validate with confidence.
LEUCINE 10X QMS
Experience the Future of Pharma
Integrate your entire shop floor in digital environment, uncover powerful insights and increase productivity.
LEUCINE 10X QMS
Resolve Market Complaints Faster
With automated triage & global regulatory compliance, we ensure swift accurate handling of market complaints.
LEUCINE 10X QMS
Streamline Change Control with AI-Driven Efficiency
Accelerate change implementations while ensuring compliance, thus releasing products faster to market
FDA TRACKER
Free FDA Form 483 Analytics Tool
Mitigate compliance risks in your pharma processes with our large repository of in-depth insights
QMS Hub
chevron left
FDA Observations CAPA

FDA Observations CAPA

Be Audit-Ready with Our Comprehensive 40+ Point Checklist that covers key areas auditors typically focus on during a pharmaceutical industry audit.

Use it to identify gaps, implement corrective measures, and fortify your CAPA process to ensure compliance and continuous improvement in pharmaceutical operations.

Please enter a business email.
Thank you! Your submission has been received!
Download PDF
Oops! Something went wrong while submitting the form.

Dive Deep into the Following Critical Aspects

Documentation

Ensure all records are complete, accurate, and easily accessible.

Process and System Review

Evaluate the efficiency and effectiveness of your processes and systems.

Regulatory Compliance

Verify adherence to all relevant regulations and standards.

Facility & Personnel

Assess the condition of your facilities and the competence of your staff.

Communication and Coordination

Check the effectiveness of internal and external communication channels.

Follow-up and Monitoring

Ensure ongoing tracking and resolution of CAPAs to maintain compliance.

Ready to Get Started?

300+ pharma facilities globally use Leucine to stay compliant. Speak with one of the expert consultants at Leucine to know how.

Schedule Demo