FDA Inspection
Patheon Puerto Rico, Inc.Patheon Puerto Rico, Inc. – FDA Inspection, Jul 12, 2022
Record Details
This FDA Inspection record concerns Patheon Puerto Rico, Inc., with an inspection on July 12, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Patheon Puerto Rico, Inc.
- Inspection Date
- July 12, 2022
- Product Type
- Drugs
View Company Profile
ID · dce33921-fc3c-466d-aa75-669fd19390f7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1174359
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Patheon Puerto Rico, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| July 31, 2026 | Not classified | San Juan District Office | Drug Quality Assurance |
| October 15, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 31, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 21, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 3, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Patheon Puerto Rico, Inc.
- FDA Inspection 1304666 - 2026-07-31
- FDA Inspection 1106702 - 2019-10-15
- FDA Inspection 1053901 - 2018-05-31
- FDA Inspection 976890 - 2016-06-21
- FDA Inspection 941475 - 2015-09-03
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.