Quality Policy

Akesoe Biologics LLC is committed to maintaining appropriate standards of quality in tissue processing and distribution, ensuring regulatory compliance at every step of our operations.

Effective Date: July 10, 2026

Company Quality Commitment

Akesoe Biologics LLC operates as an FDA-registered tissue establishment providing tissue processing and distribution services. Our quality management system is built on regulatory compliance, process controls, and established industry standards.

Our Quality Principles

Product quality standards
Compliance with FDA regulations and industry standards is non-negotiable
Continuous improvement drives our quality management system
Regulatory compliance procedures
Transparency and traceability ensure accountability throughout our supply chain
Employee competency and training are fundamental to quality assurance

Quality Headquarters:

1341 Sundial Point, Winter Springs, FL 32708

Quality Assurance Direct Line:

(407) 773-1994

Quality Management Email:

Admin@Akesoe.com

Quality Management System Framework

Our comprehensive Quality Management System (QMS) is designed to meet FDA requirements for tissue establishment operations, incorporating elements of ISO 13485 medical device quality standards and Good Tissue Practice (GTP) regulations.

QMS Core Components

Management responsibility and leadership commitment
Resource management and infrastructure planning
Process-based approach to quality control
Risk-based thinking and preventive measures
Data-driven decision making and analysis
Continuous improvement and corrective actions

Regulatory Alignment

21 CFR Part 1271: Human Cells, Tissues, and Cellular Products
FDA Guidance for Industry: Eligibility Determination
Current Good Tissue Practice (cGTP) requirements
International Council for Harmonisation (ICH) guidelines
AATB Standards for Tissue Banking operations
State licensing and regulatory requirements

FDA Regulatory Compliance

21 CFR Part 1271 Compliance

Our operations strictly adhere to FDA regulations governing human cells, tissues, and cellular and tissue-based products (HCT/Ps), ensuring complete regulatory compliance throughout our processes.

Establishment registration with FDA (Current)
Product listing and classification maintenance
Donor eligibility determination protocols
Good Tissue Practice (GTP) implementation
Labeling and record-keeping compliance

Adverse reaction reporting (FDA Form 3500A)
Inspection readiness and compliance monitoring
Current Good Manufacturing Practice (cGMP) principles
Environmental monitoring and facility validation
Change control and deviation management

FDA Registration Status

Akesoe Biologics LLC maintains current FDA establishment registration and product listings. All processing activities are conducted in compliance with applicable FDA regulations and guidance documents. Regular regulatory updates ensure ongoing compliance with evolving requirements.

Tissue Processing Quality Standards

Our tissue processing operations maintain appropriate quality controls, utilizing validated procedures and qualified equipment in accordance with FDA regulations.

Processing Controls

Validated processing procedures
Environmental monitoring (ISO Class 7)
Personnel gowning and hygiene protocols
Equipment qualification and calibration
In-process testing and verification
Sterility assurance and bioburden control

Amniotic Membrane Processing

Aseptic processing techniques
Controlled rate freezing protocols
Membrane integrity testing
Barrier characteristic preservation
Physical integrity validation
Final product characterization

Quality Testing

Tissue integrity assessment
Sterility assurance testing
Bioburden evaluation
Endotoxin testing
Packaging validation
Stability and shelf-life testing

Donor Screening & Safety Protocols

Comprehensive Donor Eligibility

Our donor screening program is conducted in accordance with FDA requirements, implementing medical and social history evaluation, physical examination, and laboratory testing as specified in applicable regulations.

Medical History Review

Comprehensive prenatal and delivery records
Infectious disease screening questionnaire
High-risk behavior assessment
Travel history and exposure evaluation
Medication and substance use review

Laboratory Testing Panel

HIV-1/HIV-2 (NAT and serology)
HBV, HCV (NAT and serology)
HTLV-I/II, CMV, Syphilis
West Nile Virus, Zika Virus
Additional testing per FDA guidance

Safety Exclusion Criteria

Donors are excluded based on FDA regulations and AATB standards, including high-risk behaviors, positive infectious disease markers, certain medications, and medical conditions that may compromise tissue safety. Our exclusion criteria are regularly updated to reflect current scientific knowledge and regulatory guidance.

Cold Chain Management & Temperature Control

Maintaining precise temperature control throughout the tissue processing and distribution chain is critical to preserving tissue integrity and ensuring product quality from collection to end-user delivery.

Storage Requirements

Cryogenic storage at -80°C ± 10°C for frozen products
Refrigerated storage at 2-8°C for fresh tissues
Room temperature storage for lyophilized products
Validated freezer and refrigerator systems
Backup power and alarm systems
Continuous temperature monitoring and recording

Distribution Controls

Qualified shipping containers and dry ice protocols
Temperature data loggers in every shipment
Transit time validation studies
Courier training and certification programs
Delivery confirmation and temperature verification
Temperature excursion investigation procedures

Temperature Monitoring Technology

Our facility utilizes advanced temperature monitoring systems with continuous surveillance, automatic alerts, and redundant backup systems. All temperature-sensitive areas are continuously monitored with data logging and trend analysis capabilities.

Traceability & Chain of Custody

Complete traceability from donor to end-user is maintained through comprehensive documentation and electronic tracking systems, ensuring full accountability and enabling rapid response to any quality issues.

Comprehensive Tracking System

Unique donor identification numbers
Lot and batch tracking throughout processing
Chain of custody documentation
Processing record linkage
Distribution tracking to end users

Electronic database management
Barcode and QR code identification
Real-time inventory tracking
Expiration date monitoring
Recall capability within 24 hours

Data Integrity Standards

All traceability data is maintained in secure, validated computer systems with audit trails, electronic signatures, and backup procedures. Data integrity is ensured through access controls, change management protocols, and regular system validation activities.

Laboratory Testing & Validation

Microbiological Testing

Sterility testing (USP <71>)
Bioburden assessment
Endotoxin testing (LAL)
Environmental monitoring
Water system testing
Equipment surface monitoring

Product Testing

Tissue assessment procedures
Chemical analysis
Protein testing
Nucleic acid testing
Histological examination
Physical properties testing

Process Validation

Installation qualification (IQ)
Operational qualification (OQ)
Performance qualification (PQ)
Continued process verification
Method validation studies
Stability and shelf-life testing

Continuous Improvement & CAPA

Our commitment to continuous improvement drives systematic evaluation of processes, implementation of corrective and preventive actions (CAPA), and ongoing enhancement of quality systems.

Quality Metrics & KPIs

Donor acceptance and rejection rates
Processing yield and efficiency metrics
Sterility test pass rates
Customer complaint trending
Deviation and CAPA effectiveness
Supplier performance monitoring

CAPA Process

Root cause analysis methodology
Risk assessment and impact evaluation
Corrective action implementation
Preventive action planning
Effectiveness verification
Trend analysis and system improvements

Management Review Process

Senior management conducts quarterly quality reviews, evaluating system performance, reviewing quality metrics, assessing regulatory compliance, and ensuring adequate resources for continuous improvement initiatives.

Training & Personnel Competency

All personnel involved in tissue processing operations receive comprehensive training and demonstrate competency before performing regulated activities, with ongoing education and assessment programs.

Core Training Requirements

FDA regulations and GTP requirements
Aseptic processing techniques
Quality systems and documentation
Contamination control and hygiene
Emergency procedures and safety protocols
Equipment operation and maintenance

Competency Assessment

Written examinations and practical demonstrations
Direct observation and performance evaluation
Annual recertification requirements
Continuing education and skill updates
Documentation of training records
Performance improvement planning

Document Control & Management

Our document control system ensures that all quality-related documents are current, authorized, and accessible to personnel who need them, with proper version control and change management procedures.

Controlled Documents

Standard Operating Procedures (SOPs)
Work instructions and job aids
Quality manual and policies
Training materials and curricula
Validation protocols and reports

Specifications and acceptance criteria
Regulatory correspondence and submissions
Change control procedures
Batch records and processing logs
Investigation and CAPA reports

Regulatory Reporting & Communication

Adverse Event Reporting

We maintain robust systems for detecting, investigating, and reporting adverse events associated with our tissue products in accordance with FDA regulations.

Customer complaint handling and investigation procedures
Medical device reporting (MDR) within 24-48 hours for serious events
FDA Form 3500A submission for adverse reactions
Trend analysis and risk assessment protocols
Product recall procedures and communication plans

Routine Regulatory Submissions

Annual establishment registration updates
Product listing modifications
Manufacturing changes notifications
Inspection response and follow-up

International Compliance

Health Canada licensing requirements
European Union tissue directives
Country-specific import certifications
WHO international standards compliance

Quality Department Contact Information

For quality-related inquiries, adverse event reporting, or compliance concerns, please contact our Quality Assurance department using the information below.

Quality Assurance Department

Quality Hotline:

(407) 773-1994

Quality Email:

Admin@Akesoe.com

Quality Office:

1341 Sundial Point
Winter Springs, FL 32708

Quality Response Times

Critical Issues: Immediate response (within 2 hours)
Adverse Events: Initial response within 24 hours
Customer Complaints: Acknowledgment within 2 business days
Quality Inquiries: Response within 3 business days
Regulatory Correspondence: As required by applicable regulations

Business Hours Contact

For quality emergencies, adverse events requiring immediate attention, or critical product quality issues, please call our main number at (407) 773-1994 during business hours: Monday to Friday, 8 AM to 6 PM EST.

Policy Updates & Legal Notice

This Quality Policy is reviewed annually or as needed to reflect changes in regulations, industry standards, or company operations. All updates are communicated to relevant personnel and stakeholders through our document control system.

Important Legal Disclaimer

This Quality Policy is provided for informational purposes and reflects our current quality management practices. It does not constitute a contract or warranty. Actual procedures may be updated to reflect regulatory changes, technological advances, or continuous improvement initiatives. For the most current information, please contact our Quality Assurance department directly.

Document Version: 2026.1 | Last Reviewed: July 10, 2026 | Next Review: December 2026