FDA-Inspected Site

Institute for In Vitro Sciences, Inc.

4 FDA inspections are on record for Institute for In Vitro Sciences, Inc. in Gaithersburg, United States.

Clean· No action indicated

Gaithersburg, United States · Last updated July 11, 2026

Overview

  • 4 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2025-08-07.

At a glance

Inspections

4

Form 483s

1

EIRs

2

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
4 Aug 2025 – 7 Aug 2025Human DrugsClean
25 May 2022 – 1 Jun 2022Human Drugs483View 483 →
28 Sep 2012Not recordedClean
21 Aug 2009Not recordedClean

Observations on record

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

1 Jun 2022
21 CFR 58.113(a)(1)

Mixtures: uniformity and concentration

Cited by David L Chon, Ellen A Humphrey

1 Jun 2022
21 CFR 58.63(a)

Equipment: calibration

Cited by David L Chon, Ellen A Humphrey

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 58.113(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 58.63(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Institute for In Vitro Sciences, 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