FDA Inspection
ARx LLCARx LLC – FDA Inspection, Mar 29, 2019
Record Details
This FDA Inspection record concerns ARx LLC, with an inspection on March 29, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f4e0ac1e-0e56-4d84-85aa-50b9a1eef37c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1085673
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.67(b)(2)Cleaning SOPs/schedules
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of ARx LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| June 10, 2026 | Not classified | Philadelphia District Office | Drug Quality Assurance |
| June 3, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 20, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 18, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 18, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for ARx LLC
- FDA Inspection 1306890 - 2026-06-10
- FDA Inspection 1170966 - 2022-06-03
- FDA Inspection 1151907 - 2021-08-20
- FDA Inspection 988507 - 2016-08-18
- FDA Inspection 867422 - 2014-02-18
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