FDA Inspection
Patheon Biologics (NJ) LLCPatheon Biologics (NJ) LLC – FDA Inspection, Apr 9, 2018
Record Details
This FDA Inspection record concerns Patheon Biologics (NJ) LLC, with an inspection on April 9, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 0d574105-ecc7-4f55-a96a-7bd2e062fcb3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1049824
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Patheon Biologics (NJ) LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 26, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 13, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 23, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Patheon Biologics (NJ) LLC
- FDA Inspection 914519 - 2015-02-13
- FDA Inspection 850035 - 2013-09-26
- FDA Inspection 744300 - 2011-09-13
- FDA Inspection 653045 - 2010-03-23
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