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Bottone LLC — FDA Facility Profile

FEI 3015188315

Bottone LLC is an FDA-inspected facility (FEI 3015188315) located in Reno, NV, US. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Aug 13, 2021: Voluntary Action Indicated (VAI)
Inspections on record
3 (1 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

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 13, 2021Voluntary Action Indicated (VAI)Plant construction and design (21 CFR 117.20(b))
Personnel (21 CFR 114.10)
Process filing (21 CFR 108.25(c)(2))
Jul 26, 2011No Action Indicated (NAI)No citations listed
Aug 13, 2009No Action Indicated (NAI)Using pH meter (21 CFR 114.80(a)(2))
Code - required elements (21 CFR 114.80(b))
Scheduled process establishment (21 CFR 114.83)
Registration (21 CFR 108.25(c)(1))
and 2 more

Facility details

Company
Bottone LLC
Location
Reno, NV (US)
Source
inspections

FDA data resources

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