FDA Inspection
Niva Medical OyNiva Medical Oy – FDA Inspection, Sep 15, 2017
Record Details
This FDA Inspection record concerns Niva Medical Oy, with an inspection on September 15, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3cdb2616-f73f-4fb8-bed1-57f6347831cf
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1026499
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.134(a)Correct labels during finishing operations
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.22(a)Contract drug products--lack of responsibility
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.67(b)Written procedures not established/followed
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