Atlas

FDA-Inspected Site

GVS TM, Inc

12 FDA inspections are on record for GVS TM, Inc in Covina, United States.

483· Form 483 issued

Covina, United States · Last updated July 10, 2026

Overview

  • 12 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-05-01.

At a glance

Inspections

12

Form 483s

5

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
21 Apr 2026 – 1 May 2026Biologics483View 483 →
18 Sep 2023 – 22 Sep 2023BiologicsClean
24 Sep 2019 – 25 Sep 2019Human Drugs483On file
7 May 2018 – 15 May 2018Medical Devices & Rad Health483View 483 →
14 Aug 2014 – 19 Aug 2014Medical Devices & Rad HealthClean
8 Nov 2012Not recorded483View 483 →
18 Mar 2011Not recordedClean
25 Jun 2010Not recorded483View 483 →
31 Jan 2008Not recordedClean
23 May 2006Not recordedClean
18 Mar 2004Not recordedClean
6 Aug 2002Not recordedClean

Observations on record

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

1 May 2026
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Laurissa S Flowers, Emily B Camire, Homero W Aguilar

1 May 2026
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Laurissa S Flowers, Emily B Camire, Homero W Aguilar

1 May 2026
21 CFR 211.103

Actual vs. theoretical yields not determined

Cited by Laurissa S Flowers, Emily B Camire, Homero W Aguilar

1 May 2026
21 CFR 211.110(a)

Written in-process control procedures

Cited by Laurissa S Flowers, Emily B Camire, Homero W Aguilar

1 May 2026
21 CFR 211.115(b)

Reprocessing/quality control unit

Cited by Laurissa S Flowers, Emily B Camire, Homero W Aguilar

Investigators

FDA investigators tied to this site in the record.

Marcus F Yambot2 insp.
Carla J Lundi2 insp.
Laurissa S Flowers1 insp.
Emily B Camire1 insp.
Homero W Aguilar1 insp.
Sunitha K Rajaram1 insp.
Truong X Nguyen1 insp.
Binh T Nguyen1 insp.
Minh D Phan1 insp.
Jocelyn E Massey1 insp.
Michael F Schuette1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.194(a)Cited across public-safe Form 483 observations3x
21 CFR 211.68(b)Cited across public-safe Form 483 observations3x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.103Cited across public-safe Form 483 observations1x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.115(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(b)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(6)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(c)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.80(a)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 GVS TM, 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