FDA Inspection
Paradox IncParadox Inc – FDA Inspection, Dec 27, 2017
Record Details
This FDA Inspection record concerns Paradox Inc, with an inspection on December 27, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Daniel R. Hurt (Issuing Officer)
- Veronica Fuentes (FDA Associated Person)
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ID · eb55c800-45b8-4230-b478-f8e77017cad3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1036549
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.198(b)(1)Complaint Record required information
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
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Other FDA inspections of Paradox Inc
7| Date | Classification | Office | Project area |
|---|---|---|---|
| October 11, 2024 | Not classified | Kansas City District Office | |
| August 4, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 6, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 2, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 7, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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