FDA Inspection
Intercos Europe S.p.AIntercos Europe S.p.A – FDA Inspection, Mar 15, 2024
Record Details
This FDA Inspection record concerns Intercos Europe S.p.A, with an inspection on March 15, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · baa1c40c-0753-47a4-9eeb-6fa8b75e2b0e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1232950
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.84(b)Representative Samples Criteria
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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Other FDA inspections of Intercos Europe S.p.A
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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