FDA Inspection
CorePharma, LLCCorePharma, LLC – FDA Inspection, Feb 25, 2011
Record Details
This FDA Inspection record concerns CorePharma, LLC, with an inspection on February 25, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- CorePharma, LLC
- Inspection Date
- February 25, 2011
- Product Type
- Drugs
View Company Profile
ID · 7c965600-d4e5-469c-90e0-b5e4bb47c52e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 714277
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.111Establishment of time limitations
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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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