FDA Inspection
Paradox IncParadox Inc – FDA Inspection, Sep 2, 2015
Record Details
This FDA Inspection record concerns Paradox Inc, with an inspection on September 2, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Paradox Inc
- Inspection Date
- September 2, 2015
- Product Type
- Drugs
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ID · c537f2ff-ee75-4c8c-862b-0583b499264b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 946214
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| December 27, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 6, 2017 | 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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