503b Outsourcing Facility Automation

Engineered systems for compliant, high-volume sterile filling, labeling, and packaging operations.

Trusted 503b Packaging Solutions for 60 Years

FP Developments provides automation systems purpose-built for 503B outsourcing facilities that demand high throughput, data integrity, and regulatory compliance.

Our modular filling and labeling platforms are designed for cGMP environments and deliver unmatched precision, traceability, and repeatability. Whether you’re expanding production or upgrading existing lines, our solutions are engineered to meet FDA 21 CFR Part 11 and USP <797>/<800> standards with confidence.

Every FP Developments project is a partnership—from system design through validation and service. With more than six decades of experience in automation for pharmaceutical manufacturing, we help your operation run smarter, safer, and faster.

503b Vial Extraction and Label Removal

Our simple, tabletop solutions for 503b are ever evolving and deliver operational efficiency and regulatory compliance in a small footprint. Our machines are customizable to meet the needs of your evolving business and 100% designed, fabricated, assembled, and serviced by FP Developments.

FP Developments - Semi-Automated Vial Extraction Machine

Desktop Vial Extraction

Tabletop vial extractor: 1,000 vials/hour, <5-min changeovers, safe auto-ejection—fast, accurate, efficient processing.

Automated Syringe Filling Pump

Our Rotary Model pump delivers a streamlined path to USP compliance while strengthening sterility assurance.

Some Frequently Asked Questions

A 503B outsourcing facility produces sterile drug products in bulk without patient-specific prescriptions, following current Good Manufacturing Practice (cGMP) guidelines under FDA oversight.

503A pharmacies serve individual prescriptions; 503B facilities manufacture sterile medications in larger batches for hospitals and clinics, meeting stricter FDA and cGMP standards.

Observations often relate to inadequate environmental monitoring, deficient aseptic process validation, or data integrity issues in batch documentation.

Through validated aseptic processes, media fills, cleanroom qualification, and rigorous in-process testing to ensure each batch meets sterility and endotoxin limits.

Typical categories include ready-to-administer syringes, ophthalmic solutions, anesthetics, and drug shortage replacement formulations.

Growth is driven by hospital demand for supply stability, FDA enforcement consistency, and ongoing drug shortages that favor trusted outsourcing partners.

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Contact FP Developments

Ready to enhance your production capabilities with precision and innovation? Whether you’re looking to optimize an existing line, implement cutting-edge automation, or develop a custom solution, FP Developments Inc. is here to help. With over 60 years of expertise in pharmaceutical, biotech, and medical device packaging and machinery, we deliver solutions that meet your unique challenges.

Get in Touch Today

Connect with us to learn more about how we can support your business:

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On-staff Hospital Pharmacist:

Our team is ready to answer your questions, offer insights, and provide tailored solutions to meet your manufacturing and compliance needs.

Let’s create a solution that works for you—today and tomorrow.

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