Atlas

FDA-Inspected Site

Genlabs Corporation

9 FDA inspections are on record for Genlabs Corporation in Chino, United States.

483· Form 483 issued

Chino, United States · Last updated July 9, 2026

Overview

  • 9 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2021-12-09.

At a glance

Inspections

9

Form 483s

6

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
29 Nov 2021 – 9 Dec 2021Human DrugsWLView 483 →
20 Jul 2017 – 21 Jul 2017Human Drugs483View 483 →
7 Dec 2015 – 11 Dec 2015Human Drugs483View 483 →
9 Dec 2011Not recorded483View 483 →
10 Nov 2010Not recorded483View 483 →
20 Jan 2010Not recorded483On file
12 Mar 2009Not recordedClean
30 Jul 2002Not recordedClean
19 Mar 2001Not recordedClean

Observations on record

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

9 Dec 2021
21 CFR 211.160(b)(4)

Written calibration procedures

Cited by Santiago Gallardo Johnson, Claudia M Perez-Kasmarski

9 Dec 2021
21 CFR 211.165(a)

Testing and release for distribution

Cited by Santiago Gallardo Johnson, Claudia M Perez-Kasmarski

9 Dec 2021
21 CFR 211.165(d)

Acceptance criteria for sampling & testing

Cited by Santiago Gallardo Johnson, Claudia M Perez-Kasmarski

9 Dec 2021
21 CFR 211.180(e)(1)

Review of representative number of batches

Cited by Santiago Gallardo Johnson, Claudia M Perez-Kasmarski

9 Dec 2021
21 CFR 211.184(d)

Labeling: documentation of exam and review

Cited by Santiago Gallardo Johnson, Claudia M Perez-Kasmarski

Investigators

FDA investigators tied to this site in the record.

Santiago Gallardo Johnson2 insp.
Marcus F Yambot2 insp.
Claudia M Perez-Kasmarski1 insp.
Nicholas L Hunt1 insp.
Djamila Harouaka1 insp.
Virgilio F Pacio1 insp.
Cntrctmntr Kelley1 insp.
John A Gonzalez1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.63Cited across public-safe Form 483 observations3x
21 CFR 211.67(b)Cited across public-safe Form 483 observations3x
21 CFR 211.160(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations2x
21 CFR 211.165(a)Cited across public-safe Form 483 observations2x
21 CFR 211.165(c)Cited across public-safe Form 483 observations2x
21 CFR 211.180(e)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.67(a)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(d)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.184(d)Cited across public-safe Form 483 observations1x
21 CFR 211.188(a)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited 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 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.56(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(1)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 Genlabs Corporation'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