Top FDA Form 483 Observations: Facility Design

1. Building and facilities are not maintained to ensure that products manufactured meet the quality

Summary
Filters and facilities are shown to be damaged, leading to risks of contamination from the environment and previous products.
Excerpt from Observation
Filters of vour randomly selected Air Purification Units... were severely damaged and torn in many sections.

Justification
Observation discusses poor facility maintenance, specifically mentioning damaged filters and contaminated areas.

Possible Root Cause
Inadequate facility design and maintenance allowing for physical degradation and contamination.

Corrective Actions
Immediate repair and replacement of damaged filters and compromised areas; thorough cleaning and decontamination of affected equipment.

Preventive Actions
Implement regular maintenance schedules and robust structural integrity checks to prevent recurrence.

View detailed analysis of this observation 

Reference FDA 483:
Company Name: Granules India Limited
Issue Date: 2024-09-06
Inspection Dates: 26-08-2024 to 06-09-2024
Investigators: Pratik S Upadhyay, Joseph A Piechocki

2. Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.

Summary
Aseptic processing areas lacked appropriate air quality certifications and proper HEPA filter testing protocols.

Excerpt from Observation
Air supply that is filtered through high-efficiency particulate air filters under positive pressure.

Justification
Issues in facility design affecting environmental control and air quality.

Possible Root Cause
Insufficient design and maintenance protocols for air handling systems in production areas.

Corrective Actions
Redesign the air handling system to ensure continuous positive pressure and proper air filtration.

Preventive Actions
Conduct regular audits and maintenance of air handling systems to ensure ongoing compliance with air quality standards.

View detailed analysis of this observation

Reference FDA 483:
Company Name: Belcher Pharmaceuticals, LLC
Issue Date: 2024-08-16
Inspection Dates: 07-08-2024 to 16-08-2024
Investigators: Jessica P Mcalister, Kayla V Sprague

3. Facilities and equipment are not maintained in a manner that prevents contamination of APIs by other materials.

Summary
Facility and equipment maintenance issues result in potential contamination of APIs by other materials.
Excerpt from Observation
Liquid was observed surrounding the unidentified pipe... dripping on the floor and cover of the equipment.

Justification
The observation identifies facility design and maintenance issues that directly lead to potential contamination of APIs.  

Possible Root Cause
Inadequate facility design and maintenance protocols allowing leaks to occur, leading to potential contamination risks.

Corrective Actions
Identify and repair the leaking pipes, ensure proper sealing, and clean all affected areas to prevent contamination.

Preventive Actions
Implement regular inspection schedules and maintenance protocols for facility infrastructure; ensure proper design to manage spills and leaks.

View detailed analysis of this observation

Reference FDA 483:
Company Name: Global Calcium Pvt. Limited
Issue Date: 2024-08-02
Inspection Dates: 29-07-2024 to 02-08-2024
Investigators: Justin A Boyd, Teresa I Navas

4. Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.

Summary
Procedures to prevent microbiological contamination during aseptic filling were not followed, and filling line design issues noted.

Excerpt from Observation
The Vial Filling Line is not designed to minimize crossing the Grade A laminar flow area through a conveyor.

Justification
The design of the vial filling line was a contributing factor to contamination risks by necessitating multiple crossings.

Possible Root Cause
Design flaws in the filling line that forced personnel and equipment to cross contaminated areas.

Corrective Actions
Redesign the filling line to minimize or eliminate the need for personnel and equipment crossings through Grade A areas.

Preventive Actions
Conduct a comprehensive review of facility designs to ensure they support contamination control measures.

View detailed analysis of this observation

Reference FDA 483:
Company Name: Biocon Biologics Limited
Issue Date: 2024-07-26
Inspection Dates: 15-07-2024 to 26-07-2024
Investigators: Justin A Boyd , Teresa I Navas, Richard Ledwidge, Xiaoshi Wang

5. Firm failed to maintain an adequate clean washing facility for personnel.

Summary
Inadequate washing facilities in men's washroom and cleanroom: lack of hot water and hand drying means.

Excerpt from Observation
The men's washroom within (b) (4) API Plant failed to provide hot water.

Justification
Facility design includes the installation and maintenance of adequate washing facilities.

Possible Root Cause
Insufficient maintenance and infrastructure support for water heating systems within the facility.

Corrective Actions
Inspect and repair or upgrade the water heating system to provide sufficient hot water.

Preventive Actions
Establish a periodic maintenance schedule for all washroom facilities to ensure consistent functionality.

View detailed analysis of this observation

Reference FDA 483:
Company Name: Torrent Pharmaceuticals Limited
Issue Date: 2024-06-12
Inspection Dates: 03-06-2024 to 12-06-2024
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.