FDA Inspection
Patheon Biologics (NJ) LLCPatheon Biologics (NJ) LLC – FDA Inspection, Sep 26, 2013
Record Details
This FDA Inspection record concerns Patheon Biologics (NJ) LLC, with an inspection on September 26, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Patheon Biologics (NJ) LLC
- Inspection Date
- September 26, 2013
- Product Type
- Drugs
View Company Profile
ID · fcee91b1-5246-4e6f-b788-6447714e82d2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 850035
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Patheon Biologics (NJ) LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 9, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 13, 2015 | NAI | 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 1049824 - 2018-04-09
- FDA Inspection 914519 - 2015-02-13
- FDA Inspection 744300 - 2011-09-13
- FDA Inspection 653045 - 2010-03-23
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