FDA Inspection
Diora Kimya Sanayi ve Ticaret Limited SirketiDiora Kimya Sanayi ve Ticaret Limited Sirketi – FDA Inspection, May 31, 2024
Record Details
This FDA Inspection record concerns Diora Kimya Sanayi ve Ticaret Limited Sirketi, with an inspection on May 31, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7b61d909-c628-423c-87c0-9bc688549466
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1240100
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
FDA Citations
17- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.165(a)Testing and release for distribution
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