FDA Inspection
CoreRX Inc.CoreRX Inc. – FDA Inspection, Jun 21, 2019
Record Details
This FDA Inspection record concerns CoreRX Inc., with an inspection on June 21, 2019, issued by the Florida District Office, covering human drugs.
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ID · b803f376-82ec-4a52-865c-0160cdf3770b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1094038
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.68(a)Written calibration / inspection records not kept
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Other FDA inspections of CoreRX Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| February 26, 2026 | Not classified | Florida District Office | Drug Quality Assurance |
| March 20, 2025 | Not classified | Florida District Office | Vaccine, Allergenic, and Live Biotherapeutic Products |
| August 13, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 6, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 14, 2019 | Not classified | Florida District Office |
Other documents for CoreRX Inc.
- FDA Inspection 1304588 - 2026-02-26
- FDA Inspection 1264769 - 2025-03-20
- FDA Inspection 1151289 - 2021-08-13
- FDA Inspection 1119912 - 2020-03-06
- FDA Inspection 1105141 - 2019-06-14
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