FDA, CE, and ISO paperwork: what buyers ask before they approve a vial plant

Quick disclaimer, because this topic sits next to regulated supply chains: we make packaging. Your QA team owns how those vials fit your finished-product filings. What follows is the document set purchasing usually requests from us — not legal advice.

When a new US account opens a thread, the first attachment request is almost always the same: current ISO 13485 certificate, CE-related files if they sell into Europe as well, and whatever FDA-facing manufacturing evidence matches the SKU. Logos on a homepage don’t count. Scanned certificates with expiry dates do.

Beyond the PDF

Paper is step one. Step two is boring and useful: Can we get a lot-linked COA with the shipment? What’s the written defect threshold? Who owns CAPA when a carton shows cosmetic chips? Plants that hesitate here are plants you shouldn’t rush into a container with.

We keep cleanroom controls on the lines used for these vials and target defect rates under 0.01%. That figure only helps you if your incoming inspection plan can check it. Ask for how we sample and how we quarantine a bad lot. If the answer is vague, keep asking.

A short buyer checklist

• Certificate scope matches glass vial / medical packaging work, not an unrelated workshop.
• Dates are current; ask what happens at renewal.
• Sample carton includes the same document style you’ll get on bulk.
• Label claim language is reviewed by your side before mass print.

Need the pack for a specific vial size? Say so on the sample form — we’ll attach what we can send without waiting for a full PO.

Related: Requesting samples · About Yunhon