FDA-Inspected Site

Spa De Soleil, Inc.

9 FDA inspections are on record for Spa De Soleil, Inc. in Sun Valley, United States.

483· Form 483 issued

Sun Valley, United States · Last updated July 9, 2026

Overview

  • 9 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-01-26.

At a glance

Inspections

9

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
20 Jan 2026 – 26 Jan 2026Human Drugs483View 483 →
13 Sep 2021 – 17 Sep 2021Human Drugs483View 483 →
20 Jun 2017 – 23 Jun 2017Human Drugs483View 483 →
24 Feb 2011Not recordedClean
5 Mar 2010Not recordedClean
28 Jan 2010Not recorded483On file
1 Mar 2007Not recordedClean
24 Aug 2004Not recordedClean
9 Jul 2004Not recordedClean

Observations on record

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

26 Jan 2026
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Gloria E Andia

26 Jan 2026
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Gloria E Andia

26 Jan 2026
21 CFR 211.180(e)

Records reviewed annually

Cited by Gloria E Andia

26 Jan 2026
21 CFR 211.192

Written record of investigation incomplete

Cited by Gloria E Andia

26 Jan 2026
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Gloria E Andia

Investigators

FDA investigators tied to this site in the record.

Lisa Shin1 insp.
Ademola O Daramola1 insp.
Cntrctmntr Kelley1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations3x
21 CFR 211.67(b)Cited across public-safe Form 483 observations3x
21 CFR 211.122(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.180(e)Cited across public-safe Form 483 observations2x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.130Cited across public-safe Form 483 observations1x
21 CFR 211.165(c)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.186(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.80(a)Cited across public-safe Form 483 observations1x
21 CFR 211.80(d)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Spa De Soleil, Inc.'s 4 Form 483s

Verbatim observations 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