Diora Kimya Sanayi ve Ticaret Limited
Form 483 issued May 31, 2024 · Gaziantep, Turkey
- Inspection
- May 27 – May 31, 2024
- Investigator
- Mindy M. Chou
- Observations
- 17
- Pages
- 8
- FEI number
- 3013927966
In short: On May 31, 2024, FDA issued a Form 483 with 17 observations to Diora Kimya Sanayi ve Ticaret Limited in Gaziantep, Turkey (FEI 3013927966) after an inspection that ran May 27 – May 31, 2024. The investigator was Mindy M. Chou. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks authority to review production records to assure that…
- 02
Employees are not given training in…
- 03
Written procedures are not established for evaluations conducted at least annually to review records associated with…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Mindy M. Chou
37 documents · 2015–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New York.
The firmDiora Kimya Sanayi ve Ticaret Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Diora Kimya Sanayi ve Ticaret Limited?
FDA listed 17 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Diora Kimya Sanayi ve Ticaret Limited?
Mindy M. Chou is named on this Form 483, for the inspection of May 27 – May 31, 2024. Each investigator has a profile showing what they cite most.
When was Diora Kimya Sanayi ve Ticaret Limited inspected by FDA?
The inspection ran May 27 – May 31, 2024, and the Form 483 is dated May 31, 2024.
How do I get the full Form 483 for Diora Kimya Sanayi ve Ticaret Limited?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.