FDA Inspection
Solupharm Pharmazeutische Erzeugnisse GmbhSolupharm Pharmazeutische Erzeugnisse Gmbh – FDA Inspection, Sep 22, 2014
Record Details
This FDA Inspection record concerns Solupharm Pharmazeutische Erzeugnisse Gmbh, with an inspection on September 22, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 22, 2014
- Product Type
- Drugs
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ID · c908fb5d-c6bd-4cce-b87e-b0efe196fe69
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 897666
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.111Deviations of production time limits
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Solupharm Pharmazeutische Erzeugnisse Gmbh
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 29, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 2, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 21, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 22, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Solupharm Pharmazeutische Erzeugnisse Gmbh
- FDA Inspection 1201236 - 2022-07-29
- FDA Inspection 1039841 - 2018-02-02
- FDA Inspection 980047 - 2016-06-21
- FDA Inspection 756529 - 2011-11-22
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