FDA Inspection
Coral Pharmaceuticals LTDCoral Pharmaceuticals LTD – FDA Inspection, May 24, 2019
Record Details
This FDA Inspection record concerns Coral Pharmaceuticals LTD, with an inspection on May 24, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4c3e06d3-9482-4b37-ae0c-136a9c41e507
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1090617
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
6- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.134(b)Representative samples after completion
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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