FDA Inspection
GEN ILAC VE SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI FABRIKA SUBESIGEN ILAC VE SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI FABRIKA SUBESI – FDA Inspection, Jun 11, 2024
Record Details
This FDA Inspection record concerns GEN ILAC VE SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI FABRIKA SUBESI, with an inspection on June 11, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- June 11, 2024
- Product Type
- Human Drugs
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ID · c2bdfe62-1565-44fd-98c8-05c53dec16b3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1240829
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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