Atlas

FDA-Inspected Site

Lusys Laboratories, Inc.

7 FDA inspections are on record for Lusys Laboratories, Inc. in San Diego, United States.

483· Form 483 issued

San Diego, United States · Last updated July 10, 2026

Overview

  • 7 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2021-09-24.

At a glance

Inspections

7

Form 483s

5

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
13 Sep 2021 – 24 Sep 2021Medical Devices & Rad HealthWLView 483 →
22 Jan 2019 – 7 Feb 2019Medical Devices & Rad Health483View 483 →
1 May 2018 – 21 May 2018Medical Devices & Rad Health483View 483 →
24 Oct 2016 – 8 Dec 2016Medical Devices & Rad Health483View 483 →
20 Jan 2015 – 19 Feb 2015Medical Devices & Rad HealthWLView 483 →
20 Feb 2013 – 21 Feb 2013Medical Devices & Rad HealthClean
11 Aug 2005Not recordedClean

Observations on record

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

24 Sep 2021
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Seema S Singh

24 Sep 2021
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Seema S Singh

24 Sep 2021
21 CFR 820.160(b)

Distribution records

Cited by Seema S Singh

24 Sep 2021
21 CFR 820.160(b)

Distribution records

Cited by Seema S Singh

24 Sep 2021
21 CFR 820.70(c)

Environmental control Lack of or inadequate procedures

Cited by Seema S Singh

Investigators

FDA investigators tied to this site in the record.

Shaquenta Y Perkins3 insp.
Seema S Singh1 insp.
James A Lane1 insp.
Juanj N Wu1 insp.
Juanj Wu1 insp.
Theresa Kirkham1 insp.
Natalie J Ayoub1 insp.
Doan T Nguyen1 insp.
James R Fleckenstein1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations8x
21 CFR 820.70(c)Cited across public-safe Form 483 observations8x
21 CFR 820.72(a)Cited across public-safe Form 483 observations7x
21 CFR 820.181Cited across public-safe Form 483 observations6x
21 CFR 820.184Cited across public-safe Form 483 observations6x
21 CFR 820.20(c)Cited across public-safe Form 483 observations6x
21 CFR 820.22Cited across public-safe Form 483 observations6x
21 CFR 820.30(g)Cited across public-safe Form 483 observations6x
21 CFR 820.40Cited across public-safe Form 483 observations6x
21 CFR 820.70(g)Cited across public-safe Form 483 observations5x
21 CFR 820.80(a)Cited across public-safe Form 483 observations5x
21 CFR 820.90(a)Cited across public-safe Form 483 observations5x
21 CFR 820.198(a)Cited across public-safe Form 483 observations3x
21 CFR 820.25(b)Cited across public-safe Form 483 observations3x
21 CFR 820.30(a)Cited across public-safe Form 483 observations3x
21 CFR 820.50Cited across public-safe Form 483 observations3x
21 CFR 820.50(a)(3)Cited across public-safe Form 483 observations3x
21 CFR 820.75(a)Cited across public-safe Form 483 observations3x
21 CFR 820.160(a)Cited across public-safe Form 483 observations2x
21 CFR 820.160(b)Cited across public-safe Form 483 observations2x
21 CFR 820.250(a)Cited across public-safe Form 483 observations2x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations1x
21 CFR 820.20(b)Cited across public-safe Form 483 observations1x
21 CFR 820.30(b)Cited across public-safe Form 483 observations1x
21 CFR 820.80(d)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Lusys Laboratories, Inc.'s 5 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