FDA-Inspected Site

Coty US LLC

3 FDA inspections are on record for Coty US LLC in Sanford, United States.

483· Form 483 issued

Sanford, United States · Last updated July 9, 2026

Overview

  • 3 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2021-10-27.

At a glance

Inspections

3

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
19 Oct 2021 – 27 Oct 2021Human Drugs483View 483 →
22 Mar 2017Foods & CosmeticsClean
12 Jan 2012Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

27 Oct 2021
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Kemejumaka N Opara

27 Oct 2021
21 CFR 211.137(a)

Expiration date lacking

Cited by Kemejumaka N Opara

27 Oct 2021
21 CFR 211.165(a)

Testing and release for distribution

Cited by Kemejumaka N Opara

27 Oct 2021
21 CFR 211.182

Written records kept in individual logs

Cited by Kemejumaka N Opara

27 Oct 2021
21 CFR 211.196

Distribution Record Requirements

Cited by Kemejumaka N Opara

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.137(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.196Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Coty US LLC's 1 Form 483

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat