FDA Inspection
CorePharma, LLCCorePharma, LLC – FDA Inspection, Jun 11, 2012
Record Details
This FDA Inspection record concerns CorePharma, LLC, with an inspection on June 11, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- CorePharma, LLC
- Inspection Date
- June 11, 2012
- Product Type
- Drugs
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ID · eab80477-77b5-4c9e-b2fb-8e2d8a0a6a97
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 785318
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.204Returned drug procedures in writing and followed
- 21 CFR 211.22(a)Contract drug products--lack of responsibility
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
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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
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- FDA Inspection 1087306 - 2019-03-29
- FDA Inspection 1029942 - 2017-10-13
- FDA Inspection 980585 - 2016-08-11
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