FDA Inspection
Catalent Germany Schorndorf GmbHCatalent Germany Schorndorf GmbH – FDA Inspection, Oct 26, 2016
Record Details
This FDA Inspection record concerns Catalent Germany Schorndorf GmbH, with an inspection on October 26, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 59600dc7-b577-4b90-b4b7-ee3329749191
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 996275
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| September 21, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 1066669 - 2018-09-21
- FDA Inspection 868435 - 2014-02-07
- FDA Inspection 772774 - 2012-02-10
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