# FDA 483 - ARx LLC - March 29, 2019

Source: https://www.keypedia.com/records/483/arx-llc/e8b382a8-641a-4833-b186-6c714c2a8702

> FDA 483 for ARx LLC on March 29, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ARx LLC
- Inspection Date: 2019-03-29
- 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 across its quality control and manufacturing operations. The firm failed to establish test method sensitivity, maintain proper stability programs, ensure data integrity, and adequately manage equipment cleaning and calibration. These findings indicate a lack of robust quality systems necessary for drug product manufacturing.

## Related Documents

- [483 - 2022-06-03](https://www.keypedia.com/records/483/arx-llc/294b1861-5770-4a1a-9e22-886f77cffcb4)

## Related Officers

- [Investigator](https://www.keypedia.com/people/craig-d-zagata/1e9614e4-4efe-4d11-8b85-9fd43b64d40c)
- [James Norman](https://www.keypedia.com/people/james-norman/2e917a36-505a-44ed-b4e3-3dc0ef90a1f0)
- [Consumer Safety Officer at FDA](https://www.keypedia.com/people/alice-s-tsao/b6d72ceb-de7c-413d-b104-cac3b075c170)
- [National Expert, Pharmaceutical](https://www.keypedia.com/people/simone-e-pitts/e405f1fc-4aff-4202-b216-ddbdc342d108)

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