FDA Inspection
CoreRX Inc.CoreRX Inc. – FDA Inspection, Nov 10, 2016
Record Details
This FDA Inspection record concerns CoreRX Inc., with an inspection on November 10, 2016, issued by the Florida District Office, covering human drugs.
- Office
- Florida District Office
- People
- Christie A. Garcia (Issuing Officer)
- Jessica P. Mcalister (FDA Associated Person)
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ID · 100fb894-1bd2-44db-9908-377def8e5acc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 992071
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
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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 21, 2019 | VAI | Florida District Office | Generic Drug Evaluation |
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 1094038 - 2019-06-21
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