MACLEAN-FOGG

FDA establishment 3027486076, Menomonee Falls, Wisconsin, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.

Inspections: 1
Official action indicated: 0
Last inspection ended: May 22, 2025
Warning letters: 0

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

02019

02021

02023

12025

02027

Most Cited at This Site

Inspections citing each reference

Inspections

1 inspections, newest first

Ended	Product and area	Citations	Classification
May 22, 2025	Devices · Compliance: Devices	3 cited references 21 CFR 820.250(a). Statistical techniques - Lack of or inadequate procedures Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics have not been established. 21 CFR 820.75(a). Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures. 21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.	Voluntary Action Indicated (VAI)

Identifiers

FEI number: 3027486076
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