FDA Inspection
Rotop Pharmaka GmbHRotop Pharmaka GmbH – FDA Inspection, Dec 7, 2018
Record Details
This FDA Inspection record concerns Rotop Pharmaka GmbH, with an inspection on December 7, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f376cc87-ae08-42f0-b7ce-3a7baed2c0bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1073907
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
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Other FDA inspections of Rotop Pharmaka GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 2, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Rotop Pharmaka GmbH
- FDA Inspection 1255703 - 2021-07-02
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