USA LANKA INC — FDA Facility Profile

FEI 3014193805

USA LANKA INC is an FDA-inspected facility (FEI 3014193805) located in Elmont, NY, US. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jan 29, 2025: Voluntary Action Indicated (VAI)
Inspections on record
3 (2 VAI, 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
Recalls as the recalling firm
1, latest Mar 30, 2021

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
Jan 29, 2025Voluntary Action Indicated (VAI)Sanitary operations - Plant maintenance (21 CFR 117.35(a))
Sep 14, 2022No Action Indicated (NAI)No citations listed
Feb 25, 2021Voluntary Action Indicated (VAI)Develop FSVP (21 CFR 1.502(a))

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
Mar 30, 2021Not yet classifiedF-0446-2021Motha Jelly Crystals - Mixed Fruit Flavoured Jelly, Net Wt. 100g, and 4 more products
Jelly contains undeclared FD&C yellow #5 and blue #1, and unapproved carmoisine (E122)/dye 14720/acid red 14

Facility details

Company
USA LANKA INC
Location
Elmont, NY (US)
Source
inspections

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