FDA Inspection
Patheon Puerto Rico Inc.Patheon Puerto Rico Inc. – FDA Inspection, May 4, 2010
Record Details
This FDA Inspection record concerns Patheon Puerto Rico Inc., with an inspection on May 4, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Patheon Puerto Rico Inc.
- Inspection Date
- May 4, 2010
- Product Type
- Drugs
View Company Profile
ID · 28abdf14-8b0f-47ec-8683-6e92907f9bb7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 663080
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.65(a)Equipment construction - reactive surfaces
- 21 CFR 211.198(a)Complaint Handling Procedure
- 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 Puerto Rico Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 8, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Patheon Puerto Rico Inc.
- FDA Inspection 825067 - 2013-03-28
- FDA Inspection 574468 - 2009-04-08
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