Wrist USA (Houston), Inc FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Wrist USA (Houston), Inc has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Wrist USA (Houston), Inc" is on file.

What these totals cover: FDA records filed under the name "Wrist USA (Houston), Inc" and its spelling variant "Wrist Usa (Houston)".

Latest inspection
Jun 21, 2023 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections7Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Wrist USA (Houston), Inc's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Wrist USA (Houston), Inc: FDA inspections per year 2017: 0 inspections020172018: 1 inspections120182019: 2 inspections220192020: 0 inspections020202021: 1 inspections120212022: 0 inspections020222023: 1 inspections120232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202310000
202200000
202110000
202000000
201920000
201810000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

7 inspections from Jan 15, 2013 to Jun 21, 2023.

DateSiteProductClassificationFEI
Jun 21, 2023New Orleans, LAFood/CosmeticsNo Action Indicated (NAI)3013200663
Oct 22, 2021Pasadena, TXFood/CosmeticsNo Action Indicated (NAI)1000117548
Jul 11, 2019Pasadena, TXFood/CosmeticsNo Action Indicated (NAI)1000117548
Apr 10, 2019Pasadena, TXFood/CosmeticsVoluntary Action Indicated (VAI)1000117548
Sep 19, 2018New Orleans, LAFood/CosmeticsNo Action Indicated (NAI)3013200663
Mar 25, 2014Pasadena, TXFood/CosmeticsNo Action Indicated (NAI)1000117548
Jan 15, 2013Pasadena, TXFood/CosmeticsNo Action Indicated (NAI)1000117548
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3013200663New Orleans, LA2Jun 21, 2023
FEI 1000117548Pasadena, TX5Oct 22, 2021

Wrist USA (Houston), Inc and the FDA: common questions

Has Wrist USA (Houston), Inc received an FDA warning letter?

No FDA warning letter addressed to the name "Wrist USA (Houston), Inc" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Wrist USA (Houston), Inc received an FDA Form 483?

FDA has not published a Form 483 for "Wrist USA (Houston), Inc" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Wrist USA (Houston), Inc?

The most recent FDA inspection on file ended Jun 21, 2023 at New Orleans, LA and was classified NAI. FDA has 7 inspections of Wrist USA (Houston), Inc on file.

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