FDA Inspection
Purac Biochem BVPurac Biochem BV – FDA Inspection, May 25, 2018
Record Details
This FDA Inspection record concerns Purac Biochem BV, with an inspection on May 25, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7362b98f-e84b-4df8-b2ed-58cf17b236ae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055916
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Purac Biochem BV
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 2, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 11, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 7, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Purac Biochem BV
- FDA Inspection 1204775 - 2021-11-02
- FDA Inspection 954945 - 2015-12-11
- FDA Inspection 823454 - 2013-02-07
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