Contract manufacturers: who is registered with FDA, where, and how big
Choosing or auditing a contract manufacturer starts with knowing who they are, where they operate and how large their footprint is. This beta page lists contract manufacturers from FDA’s public establishment registration and listing database, ranked by size of their public FDA footprint. It is a directory built from public records. It is not a quality ranking, a rating or a recommendation.
Beta. 8 firms so far, chosen because they appear at the top of the FDA data. The list grows every month. Spot an error or want a firm added or corrected? Write to hola@norteregulatorio.com.
| Rank · Firm (as FDA lists it) | Contract-manufacturing listings | Countries of registered sites (listings) | Address on an FDA record |
|---|---|---|---|
| #1 · Jabil Inc. name term: Jabil | 1,626 | US 802 · CH 585 · MX 124 · DE 62 · CN 26 · SG 19 · DO 7 · MY 1 | 10800 Roosevelt Blvd., Saint Petersburg, FL 33716, US |
| #2 · Straits Orthopaedics (Mfg) Sdn Bhd name term: Straits | 990 | MY 990 | PMT 850, Persiaran Cassia Selatan 8, Taman Perindustrian Batu Kawan, Bandar Cassia, 14110 Pulau Pinang, MY |
| #3 · Avalign (several entities) name term: Avalign | 735 | US 687 · DE 48 | Example record: NG Instruments, Inc dba Avalign Cutting Instruments, 4643 North State Road 15, Warsaw, IN 46582, US |
| #4 · Tecomet name term: Tecomet | 694 | US 691 · GB 3 | 5307 95th Avenue, Kenosha, WI 53144, US |
| #5 · Millstone Medical Outsourcing LLC name term: Millstone | 568 | US 568 | 580 Commerce Drive, Fall River, MA 02720, US |
| #6 · Viant Medical, LLC name term: Viant | 265 | US 220 · FR 18 · CR 14 · MX 12 · CN 1 | 2 Hampshire Street, Suite 202, Foxborough, MA 02035, US |
| #7 · The Cretex Companies, Inc. name term: Cretex | 260 | US 260 | 311 Lowell Ave., Elk River, MN 55330, US |
| #8 · Flextronics International USA, Inc. name term: Flextronics | 208 | MX 122 · SG 36 · CN 28 · US 9 · IL 8 · AT 2 · CH 2 · HU 1 | 12455 Research Blvd, Austin, TX 78759, US |
Contact: this page lists the business address FDA holds for the owner or operator. FDA also lists an official correspondent for each firm; we do not republish individual names or phone numbers. Use the company’s own website or switchboard.
Where contract manufacturing is registered, worldwide
Listings by country of the registered site (top 10), all firms: US 25,328 · CN 12,039 · DE 8,024 · MX 3,483 · MY 2,202 · CH 1,576 · FR 1,206 · PK 1,166 · TW 1,141 · IN 900
How the ranking works
- What is counted: records in openFDA
device/registrationlistingwhose establishment type is “Manufacture Medical Device for Another Party (Contract Manufacturer)”, grouped by the owner or operator name FDA holds. One record is one registered facility–product listing. The count measures how many contract-manufacturing listings a firm has registered, so it reflects breadth and scale of what is registered. It does not measure quality, capacity, price, lead time or regulatory standing. - Firm names are matched on a name term (shown in the table), so related entities with the same term can be included. Counts can change when firms update their registrations.
- Why not a “best” ranking: a fair quality ranking needs inspection, audit and performance data that is not public in a form that can be compared. We will add the neutral public signals that exist (inspection and warning-letter records, recall records) as separate columns, never merged into one score.
How to use this
- Shortlisting: find out which suppliers operate in the country and region you need, and how many listings they have.
- Diligence: confirm the exact legal entity and site for the product you are buying; FDA registration is not an approval or a quality certificate.
- Next step: check the firm’s own website, request its audit reports and certifications, and look up its FDA inspection and recall records.
Source: openFDA device/registrationlisting (meta.last_updated 2026-09-28), accessed 2026-10-11. Query base: https://api.fda.gov/device/registrationlisting.json?search=establishment_type:"Contract+Manufacturer"&count=registration.iso_country_code
DATA is read from FDA’s public records and is unvalidated by openFDA. FDA registration does not denote approval or endorsement. Listings are self-reported by firms. Informational only; not a rating, audit, endorsement or advice of any kind. Corrections: hola@norteregulatorio.com.