Diora Kimya Sanayi ve Ticaret Limited
FDA inspection history in Gaziantep, Turkey, 2024
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2024: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One warning letter and one Form 483, at Gaziantep, Turkey.
Cited most
Across all Diora Kimya Sanayi ve Ticaret Limited observations on file
- 21 CFR 211.165(a)Testing and release for distribution2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.125(a)Labeling issuance1
- 21 CFR 211.130Packaging and labeling operations1
- 21 CFR 211.160(b)General requirements1
The complete Diora Kimya Sanayi ve Ticaret Limited file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Gaziantep, Turkey
One warning letter and one Form 483 · 2024 · 17 observations
Latest: Warning letter, Oct 17, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-10-17 | Warning letter Warning letter | Gaziantep, Turkey | — | $99 |
| 2024-05-31 | 483 Form 483 | Gaziantep, Turkey | 17 | $99 |
Investigators on these documents
FEI number 3013927966 · most recent document Oct 17, 2024
About Diora Kimya Sanayi ve Ticaret Limited
How many FDA Form 483s has Diora Kimya Sanayi ve Ticaret Limited received?
FDA Intel has 1 Form 483 on file for Diora Kimya Sanayi ve Ticaret Limited; the most recent is dated May 31, 2024.
When was Diora Kimya Sanayi ve Ticaret Limited last inspected by FDA?
The most recent FDA inspection document on file for Diora Kimya Sanayi ve Ticaret Limited is a Form 483 dated May 31, 2024, for the site in Gaziantep, Turkey.
What did FDA cite at Diora Kimya Sanayi ve Ticaret Limited?
The regulations cited most in the observations on file for Diora Kimya Sanayi ve Ticaret Limited are 21 CFR 211.165(a) (Testing and release for distribution), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.125(a) (Labeling issuance), 1 time.
Has Diora Kimya Sanayi ve Ticaret Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Diora Kimya Sanayi ve Ticaret Limited; the most recent is dated Oct 17, 2024.