Compliance & Quality
FDA-registered since 1997. cGMP-compliant production. Full documentation on every order — no exceptions, no requests required.
FDA-Registered Facility
MBM Packaging Labs, Inc. is an FDA-registered establishment operating from Rogersville, Tennessee. Our facility has served the pharmaceutical and medical device industries since 1997 under current Good Manufacturing Practice standards. Registration No. 3014553709.
FDA Establishment Registration No. 3014553709.
Current Good Manufacturing Practice
Our production processes are built around cGMP requirements. Controlled access facilities, documented procedures, trained personnel, and in-house production from print through bindery — every step is managed to eliminate uncontrolled variables and maintain product integrity.
Controlled Access Facility
24/7 video surveillance and controlled product segregation throughout the facility.
In-House Production
Print and bindery operations under one roof — no outsourced steps that introduce uncontrolled variables.
Count Controls & Reject Destruction
Digital and physical count procedures at every production stage. All rejects receive documented destruction with recycling where possible.
Trained Personnel
Management team with 100+ years combined experience in printing and contract manufacturing for regulated industries.
What Ships with Every Order
Every regulated order includes a complete compliance documentation package. No requests required — it ships automatically.
Certificate of Conformance
Signed CoC confirming the order meets all specified dimensional, print, and substrate requirements.
Batch Record with Lot Traceability
Full production record with lot number, materials used, equipment, and process data for every run.
Inspection Report
Dimensional and visual inspection results measured against approved artwork and customer specifications.
Artwork Revision Log
Version-controlled record of all artwork approvals and revisions — critical for 510(k) submissions, technical files, and regulatory audits.
Audit-Ready. Quality Agreements Welcome.
We welcome supplier qualification audits and quality agreements. Our documentation practices, facility controls, and production records are maintained to support your supplier qualification process. Contact us to schedule an audit or to request our quality overview.
Questions about our quality system?
Contact us to schedule a supplier audit, request a quality agreement, or discuss your compliance requirements.