FDA Inspection
DermaPharm A/SDermaPharm A/S – FDA Inspection, Sep 19, 2019
Record Details
This FDA Inspection record concerns DermaPharm A/S, with an inspection on September 19, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 412944e0-af0e-40a6-b95d-2f6e47c32bd4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1102220
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
3- 21 CFR 211.194(a)(6)Comparison of Test Results to Specifications
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.192No written record of investigation
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