Quality, documentation and traceability
What your QA team receives with every order, how we qualify manufacturers, and how to request documents before you buy.
COA · sterility · spec sheet · SDS
Request any document before you order.
Documentation by product line
| Product line | Documents available |
|---|---|
| Packaging | Certificate of Analysis per lot · sterility certificate · product specification sheet · safety data sheet · independent lab report for RTU vials (USP <71> sterility, USP <85> endotoxin) |
| Equipment | Technical specifications · utility requirements · manuals · IQ/OQ plan and support · warranty terms |
| Parts & supplies | OEM part-number cross-reference · compatibility confirmation by model |
| Cold-chain | POLARCYL™ manufacturer validation report · pack-out instructions |
| Services | Validation reports · written SOPs · training records |
From the factory to your loading dock
- Importer of Record
- Team 4 Products LLC imports and clears FDA-regulated products into the US as Importer of Record
- Manufacturer qualification
- On-site audits and quality agreements with each manufacturer
- Lot traceability
- COA and lot number for every batch of all consumables
- Complaints & returns
- [POLICY: response time, return authorization]
- Your quality agreement
- We review and sign customer quality agreements
Quality questions
Does Team 4 Products provide a Certificate of Analysis?
Yes. A Certificate of Analysis and sterility documentation are available for each lot of sterile vials, stoppers and seals.
What is Team 4 Products’ FDA role?
Team 4 Products LLC is the US Importer of Record for the products it supplies. It handles FDA entry and customs clearance, so customers buy from a US company with lot documentation for every shipment.
Are your vials tested by an independent laboratory?
Yes. A lot of our sterile, ready-to-use 6R amber vials was tested by Eagle Analytical Services in Houston in June 2026 and passed USP <71> sterility and USP <85> bacterial endotoxin testing (less than 0.17 EU per vial). The report is available on request, alongside the lot COA.
Will you sign our quality agreement?
Yes. We review and sign customer quality agreements as part of supplier qualification.