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Compliance and quality

Regulated packaging is only as good as its documentation. Every regulated order ships with a complete package, and our facility controls are built around count accuracy and product security.

Documentation with every regulated order

Certificate of Conformance

A signed declaration that the order meets every specified requirement.

Batch record with lot traceability

The production record for the run: lot number, materials, and process data.

Inspection report

Dimensional and visual inspection results against your approved artwork and specifications.

Artwork revision log

A version-controlled record of every artwork approval and revision on the order.

Facility controls

FDA-registered, cGMP-compliant facility
Controlled access with 24/7 video surveillance
Product segregation by job and lot
Digital and physical count checks at every process step
Documented destruction of rejects and overruns, recycled whenever possible
Version-controlled artwork approvals

Download the MBM Quality Assurance guide (PDF)

Audits and quality agreements

We expect to be qualified as a supplier in your quality system. Supplier audits, quality agreements, and supplier questionnaires are welcome. Contact us to schedule a visit.

FDA Establishment Registration No. 3014553709. Registration of an establishment does not denote FDA approval, certification, or endorsement.

Aerial view of the MBM Packaging Labs facility in Rogersville, Tennessee — Our Rogersville, Tennessee campus: 15,000 sq ft of printing and bindery, plus 65,000 sq ft for kit assembly, warehousing, and distribution.

Aerial view of the MBM Packaging Labs campus in Rogersville, Tennessee — Our Rogersville, Tennessee campus: 15,000 sq ft of printing and bindery, plus 65,000 sq ft for kit assembly, warehousing, and distribution.

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Cartons from 50 units, IFUs from 1,000. Quotes within one business day.

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