Atlas

FDA-Inspected Site

Sky Systems Co., Inc.

8 FDA inspections are on record for Sky Systems Co., Inc. in Ontario, United States.

483· Form 483 issued

Ontario, United States · Last updated August 15, 2026

Overview

  • 8 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2020-09-30.

At a glance

Inspections

8

Form 483s

6

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
21 Sep 2020 – 30 Sep 2020Human Drugs483View 483 →
27 Feb 2017 – 2 Mar 2017Human Drugs483View 483 →
24 Oct 2011Not recorded483View 483 →
27 Jun 2011Not recorded483On file
17 Jun 2010Not recorded483View 483 →
12 Jun 2008Not recorded483On file
1 Nov 2006Not recordedClean
22 Oct 2003Not recordedClean

Observations on record

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

30 Sep 2020
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Lisa Shin

30 Sep 2020
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Lisa Shin

30 Sep 2020
21 CFR 211.165(a)

Testing and release for distribution

Cited by Lisa Shin

30 Sep 2020
21 CFR 211.166(a)

Lack of written stability program

Cited by Lisa Shin

30 Sep 2020
21 CFR 211.180(e)

Records reviewed annually

Cited by Lisa Shin

Investigators

FDA investigators tied to this site in the record.

Marcus F Yambot2 insp.
Lisa Shin1 insp.
Jolanna A Norton1 insp.
Cntrctmntr Kelley1 insp.
Babajide M Osunsanmi1 insp.
John A Gonzalez1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.180(e)Cited across public-safe Form 483 observations4x
21 CFR 211.100(a)Cited across public-safe Form 483 observations3x
21 CFR 211.166(a)Cited across public-safe Form 483 observations3x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.165(a)Cited across public-safe Form 483 observations2x
21 CFR 211.188Cited across public-safe Form 483 observations2x
21 CFR 211.111Cited across public-safe Form 483 observations1x
21 CFR 211.137(d)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 211.80(d)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(1)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 Sky Systems Co., Inc.'s 6 Form 483s

Source PDFs, 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