FDA Inspection
Kor- Chem IncKor- Chem Inc – FDA Inspection, May 5, 2023
Record Details
This FDA Inspection record concerns Kor- Chem Inc, with an inspection on May 5, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 04b94a4f-0c5b-4c0a-b5ac-e82411bb5649
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1204484
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
20- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.182Specific information required in individual logs
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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