FDA Inspection
Patheon Puerto Rico, Inc.Patheon Puerto Rico, Inc. – FDA Inspection, May 31, 2018
Record Details
This FDA Inspection record concerns Patheon Puerto Rico, Inc., with an inspection on May 31, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f6a3a5d4-7f89-4a9c-a805-c9a56d32ab3e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1053901
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.130(b)Unlabeled filled containers controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
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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 |
| July 12, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 15, 2019 | 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 1174359 - 2022-07-12
- FDA Inspection 1106702 - 2019-10-15
- FDA Inspection 976890 - 2016-06-21
- FDA Inspection 941475 - 2015-09-03
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