FDA-Inspected Site

KaryoLogic Inc

1 FDA inspection is on record for KaryoLogic Inc in Durham, United States.

483· Form 483 issued

Durham, United States · Last updated July 12, 2026

Overview

  • 1 FDA inspection is on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2025-12-19.

At a glance

Inspections

1

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
16 Dec 2025 – 19 Dec 2025Animal Drugs & Feeds483View 483 →

Observations on record

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

19 Dec 2025
21 CFR 211.105(b)

Distinctive ID or code not recorded in batch record

Cited by Marla A Cassidy, William F Lagud

19 Dec 2025
21 CFR 211.160(b)(4)

Establishment of calibration procedures

Cited by Marla A Cassidy, William F Lagud

19 Dec 2025
21 CFR 211.188

Prepared for each batch, include complete information

Cited by Marla A Cassidy, William F Lagud

19 Dec 2025
21 CFR 211.194(a)(8)

Second person sign off

Cited by Marla A Cassidy, William F Lagud

19 Dec 2025
21 CFR 211.194(c)

Testing and standardization of standards et. al.

Cited by Marla A Cassidy, William F Lagud

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 211.105(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.194(c)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind KaryoLogic Inc's 1 Form 483

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