FDA-Inspected Site

FARMAKEIO OUTSOURCING LLC

3 FDA inspections are on record for FARMAKEIO OUTSOURCING LLC in Southlake, United States.

483· Form 483 issued

Southlake, United States · Last updated July 11, 2026

Overview

  • 3 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-09-05.

At a glance

Inspections

3

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
18 Aug 2025 – 5 Sep 2025Human Drugs483View 483 →
1 Jun 2022 – 10 Jun 2022Human Drugs483View 483 →
22 Oct 2019 – 30 Oct 2019Human DrugsWLOn file

Observations on record

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

5 Sep 2025
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Camerson E Moore

5 Sep 2025
21 CFR 211.167(c)

Controlled release dosage form testing

Cited by Camerson E Moore

5 Sep 2025
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Camerson E Moore

5 Sep 2025
21 CFR 211.63

Equipment Design, Size and Location

Cited by Camerson E Moore

5 Sep 2025
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Camerson E Moore

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 211.160(b)Cited across public-safe Form 483 observations2x
FDCA 503B(a)(10)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.137(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.167(c)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind FARMAKEIO OUTSOURCING LLC's 3 Form 483s

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