Our Facility
State-of-the-art FDA-registered 503B outsourcing facility dedicated to pharmaceutical-grade sterile compounding with comprehensive quality systems and regulatory compliance.
Expertise You Can Trust
Precision Compounding was founded by a team of pharmaceutical scientists and regulatory experts with decades of combined experience in sterile manufacturing and quality assurance. Our mission is to provide healthcare professionals with reliable access to pharmaceutical-grade compounded medications that meet the highest standards of quality and safety.
As an FDA-registered 503B outsourcing facility, we operate under current Good Manufacturing Practices (cGMP) with comprehensive quality systems that ensure every product meets rigorous specifications. Our team includes licensed pharmacists, quality assurance professionals, and analytical chemists dedicated to maintaining the highest standards in sterile compounding.
We understand the critical role that compounded medications play in patient care, and we are committed to being a trusted partner for healthcare providers who demand pharmaceutical-grade quality and regulatory compliance.
Years Combined Experience
cGMP Compliant
Registered 503B
Standards Compliant
State-of-the-Art Infrastructure
Our facility is designed and equipped to meet the most stringent pharmaceutical manufacturing standards.
ISO-Classified Cleanrooms
ISO Class 5 (Class 100) cleanrooms with continuous environmental monitoring for particulate matter, temperature, and humidity control.
Advanced Analytical Lab
In-house analytical laboratory equipped with HPLC, mass spectrometry, and microbiological testing capabilities for comprehensive quality control.
Validated Processes
All manufacturing processes are validated per FDA guidance with documented protocols and ongoing process verification.
Quality Management System
Comprehensive QMS including document control, change control, CAPA, and deviation management systems.
Personnel Training
Rigorous training programs for all personnel with documented competency assessments and ongoing education requirements.
Expert Team
Licensed pharmacists, quality professionals, and analytical chemists with extensive pharmaceutical manufacturing experience.
Comprehensive Process Controls
Every step of our manufacturing process is controlled, monitored, and documented to ensure consistent quality.
Raw Material Control
- Qualified supplier program with vendor audits
- Certificate of Analysis review for all materials
- Identity testing and quality verification
- Controlled storage with environmental monitoring
Manufacturing Controls
- Validated aseptic processing techniques
- In-process controls and monitoring
- Environmental monitoring program
- Equipment qualification and calibration
Quality Testing
- Sterility testing per USP standards
- Bacterial endotoxin testing
- Potency and identity verification
- Stability testing programs
Documentation & Traceability
- Batch production records for full traceability
- Certificate of Analysis with each shipment
- Stability data and beyond-use dating
- Adverse event reporting system
Partner With Us
Experience the difference of working with a pharmaceutical-grade 503B facility committed to quality, compliance, and customer service.
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