FDA-Registered Facility
Drug establishment registration current. DUNS 031125329. Audit-ready documentation maintained continuously, not retroactively.
Quality & Compliance
Your co-packer’s regulatory posture is your regulatory posture.
For OTC products and clinical hydration, the difference between a co-packer who handles compliance and one who doesn’t is the difference between shipping on time and explaining a delay to retail buyers.
Standard
cGMP
Registration
FDA
Regulatory
SPL-Experienced
DUNS
031125329
Section 01 / cGMP Commitment
Built to 21 CFR standards, every run.
Current Good Manufacturing Practice isn’t a marketing checkbox. It’s a daily operating discipline that determines whether your batch records survive an audit.
- Validated Processes
- Mixing, filling, and packaging processes are validated and documented. Process changes go through formal review, not floor-level decisions.
- Trained Personnel
- Annual cGMP training. Role-specific SOPs. No one runs equipment they aren’t qualified on.
- Documented Procedures
- Master Batch Records, equipment cleaning logs, calibration records, deviation reports. Every action traceable to a procedure.
- Continuous Improvement
- CAPA system, internal audits, supplier qualification reviews. We treat findings as data, not embarrassment.
Section 02 / Regulatory Posture
FDA-registered. SPL-fluent. NDC-experienced.
Most liquid co-packers come from the supplement side, which means SPL submissions and OTC labeling become your team’s problem. We absorb that work because it’s already how we run.
SPL Submissions In-House
Structured Product Labeling XML prepared and submitted by us. No third-party regulatory consultants in the loop on standard work.
NDC Management
Labeler code management, product listing, label changes, and ingredient substitutions handled at our level. Your team isn’t the bottleneck.
OTC Monograph Experience
Hands-on experience with OTC monograph requirements. We know what a Drug Facts panel needs to say and what it can’t.
Section 03 / Quality Control
Tested at every checkpoint.
QC isn’t a final-shipment ritual. It’s built into every stage, so the issues that show up at release have already been resolved before they got there.
- Incoming Materials
- Identity, purity, and specification testing on every raw material lot. COA review. Rejected lots quarantined and documented.
- In-Process
- pH, density, viscosity, fill volume, and label application checks during every run. Real-time intervention, not after-the-fact rejection.
- Finished Product
- Final assay against spec, microbiology where required, label and packaging verification. Every lot.
- Documentation
- Batch records and COAs delivered with every shipment. Stored for retention periods that exceed regulatory minimums.
- Traceability
- Lot-level traceability from raw material through finished good. If a recall ever needed to happen, it would happen fast and clean.
QC Lab · Hialeah, FL
“A co-packer who doesn’t speak OTC turns every label change, every ingredient substitution, every new SKU into a regulatory drag on your team. That’s not the partnership we offer.”