FDA-Inspected Site

Diora Kimya Sanayi ve Ticaret Limited Sirketi

1 FDA inspection is on record for Diora Kimya Sanayi ve Ticaret Limited Sirketi in Gaziantep, Turkey.

483· Form 483 issued

Gaziantep, Turkey · Last updated August 15, 2026

Overview

  • 1 FDA inspection is on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2024-05-31.

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
27 May 2024 – 31 May 2024Human DrugsWLView 483 →

Observations on record

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

31 May 2024
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Mindy M Chou

31 May 2024
21 CFR 211.125(a)

Strict control not exercised over labeling issued

Cited by Mindy M Chou

31 May 2024
21 CFR 211.130

Procedures are written, and followed

Cited by Mindy M Chou

31 May 2024
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Mindy M Chou

31 May 2024
21 CFR 211.165(a)

Testing and release for distribution

Cited by Mindy M Chou

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 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.130Cited 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(e)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)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 211.194(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 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.68(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 Diora Kimya Sanayi ve Ticaret Limited Sirketi'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