FDA Inspection
Catalent Germany Schorndorf GmbHCatalent Germany Schorndorf GmbH – FDA Inspection, Sep 21, 2018
Record Details
This FDA Inspection record concerns Catalent Germany Schorndorf GmbH, with an inspection on September 21, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b23fcc36-82a0-45a0-96ff-be30919e3f28
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066669
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.188(b)(5)In-Process and Laboratory Control Results
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Other FDA inspections of Catalent Germany Schorndorf GmbH
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 17, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 14, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 26, 2016 | VAI | Center for Drug Evaluation and Research | New Drug Evaluation |
| February 7, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 10, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Catalent Germany Schorndorf GmbH
- FDA Inspection 1205903 - 2022-03-17
- FDA Inspection 1127864 - 2020-02-14
- FDA Inspection 996275 - 2016-10-26
- FDA Inspection 868435 - 2014-02-07
- FDA Inspection 772774 - 2012-02-10
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