Pharmaceuticals
Difgen
FDA 21 CFR-validated weight verification on a tight installation window.
High-Precision Checkweigher
Pharma · DSCSA · IQ/OQ/PQ
DSCSA Compliant Coding and Serialization Hardware. No Enterprise Price Tag.
Compounding pharmacies and small pharma manufacturers in the Southeast trust Factronics for laser coders, inspection systems, and serialization equipment. Full IQ/OQ/PQ documentation included.
- Turnkey installation, We install, configure, and validate. No engineering team needed.
- IQ/OQ/PQ documentation included, Ready for your next FDA audit or DSCSA inspection
- Serialization hardware (L1/L2), Unit-level 2D DataMatrix coding for DSCSA compliance
We will review your current setup and find DSCSA or FDA gaps. Free.
Regulatory Snapshot
34%
FDA inspections in Southeast up since 2023
2023
DSCSA serialization enforcement deadline (already active)
IQ/OQ/PQ
Included with every pharma installation
What Is at Stake
The FDA Does Not Wait for You to Get Ready
DSCSA Enforcement Is Active
Every unit sold must carry a unique 2D DataMatrix code since 2023. Non-compliant facilities face supply chain lockout and FDA action.
Form 483 Can Shut You Down
An FDA observation letter can halt operations within days. Most violations in small labs are documentation and equipment issues. Both fixable.
Inspectors Check Equipment Records
Calibration logs, validation docs, and maintenance records get reviewed. If you can't show them, you are already failing.
Factronics Pharma Solutions
Turnkey. From Hardware to Documentation.
Laser Coders (Linx CSL Series)
Permanent serialization on blister packs, vials, cartons, and flexible pharma packaging.
X-Ray Inspection Systems
Detects particulates in vials and blister packs at pharma-grade tolerances.
Checkweighers
In-line weight checks for capsules, vials, and unit-dose packaging.
Thermal Transfer Overprinting
Variable data printing for lot, expiry, and serial codes on flexible pharma pouches and labels.
Documentation and Validation
"We Handle the Paperwork Your FDA Auditor Will Ask For."
Included with every pharma installation:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Calibration records template
- Maintenance schedule
You don't need a validation engineer. We handle it.
Pharma Coding Installations
Linx Coders on Real Pharma Production Lines
Each installation includes IQ/OQ/PQ documentation and operator training from Factronics.
Understanding DSCSA for Small Manufacturers
What DSCSA Actually Requires from Your Facility
01
Unit-Level Serialization (L1/L2)
Every single package must have a 2D DataMatrix barcode with a unique ID, serial number, lot number, and expiry date. Factronics supplies the laser or inkjet hardware that prints these codes.
02
EPCIS Data Exchange
Your system must generate and send electronic product code data. Factronics hardware works with major EPCIS platforms like TraceLink, Covectra, and SAP.
03
Aggregation (Optional but Smart)
Bundle to case to pallet tracking gives you full supply chain traceability and simpler recalls. Ask us about options for small manufacturers.
"You Don't Need an Enterprise System. You Need the Right Hardware."
Factronics helps pharma manufacturers at L1/L2, the layer where every unit gets its unique code. That is the foundation. We make it fast, affordable, and validated.
Built for Southeast Pharma SMEs
If Any of These Sound Like You, We Should Talk
Compounding pharmacy (503A or 503B)
Generic drug manufacturer (10, 200 employees)
Small CDMO or contract packager
You've received a Form 483 or warning letter
An FDA inspection is scheduled or overdue
You're upgrading to meet DSCSA 2024/2025 requirements
Your current coding equipment lacks validation documentation
You're in FL, NC, GA, TN, or SC
Southeast USA Pharma Hubs We Serve
Deep Roots in the Southeast's Pharma Ecosystem
Miami, Tampa, Jacksonville
Florida
Compounding pharmacies, generic manufacturers, and distribution to the Caribbean and Latin America. Many FDA-regulated small labs.
Research Triangle
North Carolina
800+ pharma and biotech companies. GSK and Pfizer ecosystem. Many small labs need serialization upgrades.
Atlanta
Georgia
Growing biotech and medical packaging sector. CDC ecosystem.
Mid-Southeast
Tennessee and South Carolina
Mid-size pharma manufacturers expanding. First-time serialization installations.
Recent Results
Real Results from Real Pharma Operations
Common Questions
Things We Hear All the Time
We offer modular solutions. Start with L1/L2 hardware and scale from there. The cost of a Form 483 or a distributor rejection is far higher than any equipment investment. Ask us about financing.
Free Compliance Consultation
Is Your Pharma Line DSCSA Ready? Free Assessment.
We will review your current serialization setup, find compliance gaps, and recommend the minimum equipment to close them. No charge. No pressure.