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ENTERRA MEDICAL, INC. — FDA Facility Profile

FEI 3027386225

ENTERRA MEDICAL, INC. is an FDA-registered facility (FEI 3027386225) located in Saint Louis Park, MN, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
May 4, 2026: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
May 4, 2026Voluntary Action Indicated (VAI)Risk-based approach not applied to QMS processes (ISO 13485:2016 Clause 4.1.2)
Product realization risk management processes not documented (ISO 13485:2016 Clause 7.1)
Review of design and development do not include evaluation of change effects (ISO 13485:2016 Clause 7.3.9)
Criteria for the evaluation and selection of suppliers not established (ISO 13485:2016 Clause 7.4.1)
and 1 more

Facility details

Company
Enterra Medical, Inc.
Location
Saint Louis Park, MN (US)
Source
device

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.