# ARx LLC – FDA 483, Jun 10, 2026

Source: https://www.keypedia.com/records/483/arx-llc/4d5565e2-e8b3-4dde-bb1e-b727247dcee0

> FDA 483 for ARx LLC on June 10, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ARx LLC
- Inspection Date: 2026-06-10
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of ARX LLC, a contract human drug manufacturer in Glen Rock, PA, revealed significant deficiencies in quality control and manufacturing practices. The firm failed to thoroughly investigate confirmed microbial contamination in its USP water system, leading to the distribution of potentially impacted drug products without adequate testing. Additionally, the inspection cited failures in finished drug product release testing, deficient laboratory investigations, inadequate equipment cleaning, and poor record-keeping practices, including a repeated observation.

## Related Documents

- [483 - 2022-06-03](https://www.keypedia.com/records/483/arx-llc/294b1861-5770-4a1a-9e22-886f77cffcb4) — date: June 3, 2022
- [483 - 2019-03-29](https://www.keypedia.com/records/483/arx-llc/e8b382a8-641a-4833-b186-6c714c2a8702) — date: March 29, 2019

## Related Officers

- [Rose L. Jean-Mary](https://www.keypedia.com/people/rose-l-jean-mary/398483f5-12f7-429b-8a13-c068b41ff3ed)
- [issuing_officer](https://www.keypedia.com/people/michael-o-idowu/795647ab-8f6b-47cc-ae88-3b2c61192861)

Company: https://www.keypedia.com/companies/arx-llc/421f6fe9-46d1-4ff5-b030-2667b3cb879c

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8