Smirks Ltd — FDA Facility Profile

FEI 3013659654

Smirks Ltd is an FDA-inspected facility (FEI 3013659654) located in Fort Morgan, CO, US. RegDataLab tracks 4 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Aug 31, 2022: No Action Indicated (NAI)
Inspections on record
4 (2 VAI, 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
Recalls as the recalling firm
1, latest Jul 20, 2022

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
Aug 31, 2022No Action Indicated (NAI)No citations listed
Feb 11, 2022No Action Indicated (NAI)No citations listed
Jul 22, 2020Voluntary Action Indicated (VAI)Supplier approval - document (21 CFR 1.505(b))
Supplier verification - establish written procedures (21 CFR 1.506(b))
Sep 29, 2017Voluntary Action Indicated (VAI)Hazard analysis written (21 CFR 1.504(a))
Supplier approval - document (21 CFR 1.505(b))
Supplier verification - establish written procedures (21 CFR 1.506(b))

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Jul 20, 2022Not yet classifiedF-1543-2022Organic Amaranth, item # 4602, packaged in 25kg and supersack totes. Product is raw grain…
Potential to be contaminated with Salmonella.

Facility details

Company
Smirks Ltd
Location
Fort Morgan, CO (US)
Source
inspections

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