FDA Inspection
Europharma Concepts LimitedEuropharma Concepts Limited – FDA Inspection, Nov 3, 2017
Record Details
This FDA Inspection record concerns Europharma Concepts Limited, with an inspection on November 3, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b30c5d96-a160-49d2-b1a2-766df12cabe2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1030724
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(c)(2)Appropriate Opening of Component Containers
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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