FDA Inspection
IPR Pharmaceuticals, Inc.IPR Pharmaceuticals, Inc. – FDA Inspection, Jul 29, 2013
Record Details
This FDA Inspection record concerns IPR Pharmaceuticals, Inc., with an inspection on July 29, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- IPR Pharmaceuticals, Inc.
- Inspection Date
- July 29, 2013
- Product Type
- Drugs
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ID · fceebc3c-3cf3-4a5e-91a1-3cd375d1e80b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 844409
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.100(b)SOPs not followed / documented
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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 |
| June 14, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 26, 2015 | NAI | 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 1055499 - 2018-06-14
- FDA Inspection 942102 - 2015-08-26
- FDA Inspection 701582 - 2010-12-07
- FDA Inspection 635541 - 2009-12-21
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