FDA Inspection
Solupharm Pharmazeutische Erzeugnisse GmbhSolupharm Pharmazeutische Erzeugnisse Gmbh – FDA Inspection, Feb 2, 2018
Record Details
This FDA Inspection record concerns Solupharm Pharmazeutische Erzeugnisse Gmbh, with an inspection on February 2, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Angela E. Glenn (Issuing Officer)
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ID · 9edd0188-33c6-468e-896a-043686310d51
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1039841
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
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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 |
| June 21, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 22, 2014 | 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 980047 - 2016-06-21
- FDA Inspection 897666 - 2014-09-22
- FDA Inspection 756529 - 2011-11-22
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