FDA Inspection
CorePharma, LLCCorePharma, LLC – FDA Inspection, Sep 14, 2009
Record Details
This FDA Inspection record concerns CorePharma, LLC, with an inspection on September 14, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- CorePharma, LLC
- Inspection Date
- September 14, 2009
- Product Type
- Drugs
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ID · 98a8395e-7020-4dc1-92be-aed66f205dc0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 611676
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 314.80(c)Failure by applicant to report ADE
- 21 CFR 314.80(c)(2)Failure to report non-alert ADEs
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Other FDA inspections of CorePharma, LLC
13| Date | Classification | Office | Project area |
|---|---|---|---|
| August 28, 2025 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 12, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 29, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 13, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 11, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for CorePharma, LLC
- FDA Inspection 1280399 - 2025-08-28
- FDA Inspection 1240419 - 2024-09-12
- FDA Inspection 1087306 - 2019-03-29
- FDA Inspection 1029942 - 2017-10-13
- FDA Inspection 980585 - 2016-08-11
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