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BABYATION INC. — FDA Facility Profile

FEI 3015200642

BABYATION INC. is an FDA-registered facility (FEI 3015200642) located in Saint Louis, MO, US. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
May 28, 2026: No Action Indicated (NAI)
Inspections on record
2 (2 NAI)
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 28, 2026No Action Indicated (NAI)Reworked product not verified (ISO 13485:2016 Clause 8.3.4)
Oct 13, 2022No Action Indicated (NAI)DHR content (21 CFR 820.184)
Product rework procedures, Lack of or inadequate procedures (21 CFR 820.90(b)(2))
Design Validation - Risk analysis not performed/inadequate (21 CFR 820.30(g))

Facility details

Company
Babyation Inc.
Location
Saint Louis, MO (US)
Source
device

FDA data resources

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