Latest Form 483 issued by FDA

Common FDA 483 Observations and How to Prevent Them

1. Equipment and Utensils Are Not Cleaned at Appropriate Intervals

Summary:
Inadequate cleaning of non-dedicated manufacturing equipment for several years, potentially compromising drug product safety and quality.

Excerpt from Observation:
The (b)(4) (b)(4) non-dedicated used in the manufacturing of drug products at your firm have not been appropriately cleaned since their installation several years ago.

Justification:
Cleaning of non-dedicated equipment is crucial to prevent cross-contamination and maintain drug product quality.

Possible Root Cause:
Lack of an established or properly followed cleaning schedule and procedures for non-dedicated equipment.

Corrective Actions:
Immediately clean all non-dedicated equipment and verify cleanliness through validated cleaning methods.

Preventive Actions:
Implement a rigorous and routine cleaning schedule with proper documentation and training for all personnel involved.

View detailed analysis of this observation

Reference:
FDA 483: Granules India Limited

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Issue Date: 2024-09-06

Investigators: Pratik S Upadhyay, Joseph A Piechocki

2. Production Records Do Not Contain Complete Information

Summary:
Production records were falsified, incomplete, with manipulated data, impacting batch, cleaning, and equipment logs.

Excerpt from Observation:
Duplicate sets of cleaning records and equipment logs were created for the same time period and document different batches being manufactured on the same equipment, at the same time.

Justification:
Conflicts in cleaning records directly pertain to inappropriate equipment cleaning documentation.

Possible Root Cause:
Lack of genuine recording, oversight failures, and intentional duplicity in documents.

Corrective Actions:
Revalidate cleaning procedures, authenticate all current and future records, and ensure redundant verification.

Preventive Actions:
Introduce cross-verification of cleaning logs, with random unannounced checks by a third party.

View detailed analysis of this observation

Reference:
FDA 483: Global Calcium Pvt. Limited | Issue Date: 2024-08-02 | Investigators: Justin A Boyd, Teresa I Navas

3. Deficient Cleaning in Aseptic Processing Areas

Summary:
Deficiency in cleaning protocol in aseptic processing areas leading to potential contamination risks.

Excerpt from Observation:
Observed the operator failed to clean the legs of the ISO 5 (b)(4) air flow hood.

Justification:
Observation denotes improper handling and cleaning of critical equipment that can impact aseptic conditions.

Possible Root Cause:
Potential gaps in SOP coverage or adherence, lack of supervision.

Corrective Actions:
Review and update cleaning SOPs; ensure operators know procedures for cleaning all equipment parts.

Preventive Actions:
Schedule regular training sessions, implement reviewed SOPs, and conduct random and regular inspections.

View detailed analysis of this observation

Reference:
FDA 483: Nubratori, Inc | Issue Date: 2024-07-26 | Investigators: Lucila B Nwatu

4. Deficient Equipment Cleaning and Maintenance Procedures

Summary:
Deficient equipment cleaning and maintenance procedures led to expired and undocumented glassware usage, risking contamination.

Excerpt from Observation:
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment from contamination prior to use.

Justification:
The issue directly pertains to the cleaning of equipment, specifically in maintaining and documenting the cleanliness and expiry of the equipment used in critical processes.

Possible Root Cause:
Lack of sufficient documentation and failure to conduct necessary studies or tests to support expiry dates of equipment.

Corrective Actions:
Develop and implement thorough documentation procedures for assigning and justifying expiry dates of cleaning and maintenance equipment.

Preventive Actions:
Conduct regular reviews and audits of cleaning and maintenance records to ensure compliance; train staff on proper documentation practices.

View detailed analysis of this observation

Reference:
FDA 483: Carie Boyd Pharmaceuticals | Issue Date: 2024-06-21 | Investigators: Camerson E Moore

5. Inadequate Equipment Cleaning Procedures

Summary:
Inadequate equipment cleaning procedures and lack of quality unit oversight, risking contamination and product quality.

Excerpt from Observation:
Your (b)(4) cleaning procedure for non-dedicated manufacturing equipment cleaning is inadequate in that it does not ensure the removal of (b)(4) materials of the previously manufactured drug products to avoid potential cross-contamination.

Justification:
The issue revolves around improper cleaning of non-dedicated manufacturing equipment, directly related to the equipment cleaning process.

Possible Root Cause:
The root cause is attributed to an inadequate cleaning procedure that fails to ensure proper removal of residual materials and lack of proper adherence to existing cleaning protocols.

Corrective Actions:
Revise the cleaning procedure to ensure thorough removal of all materials and conduct thorough retraining of personnel on revised procedures.

Preventive Actions:
Implement periodic audits and validation of cleaning procedures, with continuous training and strict adherence monitoring.

View detailed analysis of this observation

Reference:
FDA 483: Torrent Pharmaceuticals Limited | Issue Date: 2024-06-12 | Investigators: Pratik S Upadhyay, Steven A Brettler

Effective Strategies to Prevent FDA 483 Observations

• Stay updated on FDA regulations: Ensure thorough knowledge of the latest GMP and quality control standards.
• Conduct regular internal audits: Proactively assess compliance to identify and correct potential issues.
• Maintain accurate documentation: Keep batch records, SOPs, and logbooks complete, current, and readily accessible.
• Implement a strong CAPA system: Address deviations swiftly through Corrective and Preventive Actions.
• Conduct mock FDA inspections: Practice readiness by simulating inspections to uncover any gaps.
• Ensure facility and equipment maintenance: Keep facilities clean and organized, with properly calibrated equipment.

Leverage QMS Software to Prevent FDA 483 Citations

An effective QMS software can help you stay ahead of compliance challenges by automating quality processes, ensuring accurate documentation, and providing real-time oversight. With Leucine’s QMS, companies can seamlessly manage deviations, implement proactive CAPA systems, and always be inspection-ready, significantly reducing the risk of receiving FDA 483 citations.

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