Atlas

FDA-Inspected Site

KVK-Tech, Inc.

2 FDA inspections are on record for KVK-Tech, Inc. in Newtown, United States.

483· Form 483 issued

Newtown, United States · Last updated July 10, 2026

Overview

  • 2 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2020-03-13.

At a glance

Inspections

2

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
4 Feb 2020 – 13 Mar 2020Human DrugsWLView 483 →
11 Jun 2019 – 13 Jun 2019Human DrugsClean

Observations on record

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

13 Mar 2020
21 CFR 211.100(a)

Changes to Procedures Not Reviewed, Approved

Cited by Nancy M Espinal, Michele Gottshall

13 Mar 2020
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Nancy M Espinal, Michele Gottshall

13 Mar 2020
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Nancy M Espinal, Michele Gottshall

13 Mar 2020
21 CFR 211.182

Chronological Order of Equipment Log Entries

Cited by Nancy M Espinal, Michele Gottshall

13 Mar 2020
21 CFR 211.188

Prepared for each batch, include complete information

Cited by Nancy M Espinal, Michele Gottshall

Investigators

FDA investigators tied to this site in the record.

Nancy M Espinal1 insp.
Michele Gottshall1 insp.
Steven P Donald1 insp.
Jaison J Eapen1 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 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited 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 211.28(c)Cited across public-safe Form 483 observations1x
21 CFR 211.56(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind KVK-Tech, Inc.'s 1 Form 483

Source PDFs 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