Moldworks Worldwide LLC

FDA establishment 3004637983, Fords, New Jersey, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.

Inspections: 3
Official action indicated: 0
Last inspection ended: Dec 9, 2025
Warning letters: 0

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

How to read this

A hatched bar is a year that is not over, so its count covers only part of the year.

02019

02021

02023

02025

02027

Most Cited at This Site

Inspections citing each reference

Inspections

3 inspections, newest first

Ended	Product and area	Citations	Classification
Dec 9, 2025	Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices	4 cited references 21 CFR 820.22. Quality audits - Lack of or inadequate procedures Procedures for quality audits have not been adequately established. 21 CFR 820.50. Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. 21 CFR 820.86. Acceptance status The acceptance status of product was not maintained. 21 CFR 820.25(b). Training records Personnel training is not documented.	No Action Indicated (NAI)
Jun 23, 2022	Devices · Compliance: Devices	None posted	No Action Indicated (NAI)
Feb 13, 2020	Devices · Compliance: Devices	1 cited reference 21 CFR 820.80(e). Documentation Acceptance activities were not adequately documented.	Voluntary Action Indicated (VAI)

Identifiers

FEI number: 3004637983
FDA firm profile: Data Dashboard

An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard and warning letters