FDA Inspection
ARx LLCARx LLC – FDA Inspection, Jun 3, 2022
Record Details
This FDA Inspection record concerns ARx LLC, with an inspection on June 3, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- ARx LLC
- Inspection Date
- June 3, 2022
- Product Type
- Drugs
View Company Profile
ID · 335fdc3a-596c-45f2-871f-005dbf494a9a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1170966
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.188(b)(11)Identification of persons involved, each significant step
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ARx LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| June 10, 2026 | Not classified | Philadelphia District Office | Drug Quality Assurance |
| August 20, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 29, 2019 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| 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 1151907 - 2021-08-20
- FDA Inspection 1085673 - 2019-03-29
- FDA Inspection 988507 - 2016-08-18
- FDA Inspection 867422 - 2014-02-18
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