FDA Inspection
Kadesh InternationalKadesh International – FDA Inspection, Nov 7, 2018
Record Details
This FDA Inspection record concerns Kadesh International, with an inspection on November 7, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 03e3e4b3-3c63-43a4-8485-b3b3d12cc232
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1071849
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
10- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.110(b)In-process materials specifications testing
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.111Establishment of time limitations
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Other FDA inspections of Kadesh International
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 15, 2021 | NAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
Other documents for Kadesh International
- FDA Inspection 1147081 - 2021-07-15
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