FDA Inspection
IPR Pharmaceuticals, Inc.IPR Pharmaceuticals, Inc. – FDA Inspection, Jun 14, 2018
Record Details
This FDA Inspection record concerns IPR Pharmaceuticals, Inc., with an inspection on June 14, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · bf5cf238-71e9-49a8-b0e5-c437f06367c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055499
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.110(a)Control procedures to monitor and validate performance
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Other FDA inspections of IPR Pharmaceuticals, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 12, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 26, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 29, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 7, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 21, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for IPR Pharmaceuticals, Inc.
- FDA Inspection 1271831 - 2025-05-12
- FDA Inspection 942102 - 2015-08-26
- FDA Inspection 844409 - 2013-07-29
- FDA Inspection 701582 - 2010-12-07
- FDA Inspection 635541 - 2009-12-21
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