FDA Inspection
Aspen SA OSD Operations Pty Ltd.Aspen SA OSD Operations Pty Ltd. – FDA Inspection, Dec 8, 2017
Record Details
This FDA Inspection record concerns Aspen SA OSD Operations Pty Ltd., with an inspection on December 8, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a201a977-7bd7-4827-8643-9f785b7470f8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034492
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.115(a)Reprocessing procedures not written or followed
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Other FDA inspections of Aspen SA OSD Operations Pty Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 23, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 12, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Aspen SA OSD Operations Pty Ltd.
- FDA Inspection 981576 - 2016-06-24
- FDA Inspection 883568 - 2014-05-23
- FDA Inspection 646901 - 2010-02-12
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