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One Umbilical Cord Lab, Inc. — FDA Facility Profile

FEI 3013913163

One Umbilical Cord Lab, Inc. is an FDA-inspected facility (FEI 3013913163) located in Richardson, TX, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Mar 12, 2020: No Action Indicated (NAI)
Inspections on record
1 (1 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
Mar 12, 2020No Action Indicated (NAI)Authority lacking to review records, investigate errors (21 CFR 211.22(a))
Defined areas of adequate size for operations (21 CFR 211.42(c))
Testing, screening, donor eligibility procedures (21 CFR 1271.47(a))
Determination based on screening and testing (21 CFR 1271.50(a))
and 10 more

Facility details

Company
One Umbilical Cord Lab, Inc.
Location
Richardson, TX (US)
Source
inspections

FDA data resources

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