Arx, LLC
FDA inspection history in Glen Rock, Pennsylvania, 2019 to 2022
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Glen Rock, Pennsylvania.
- 2019The longest 483 on file: 9 observations over 5 pages at Glen Rock, Pennsylvania.
- 2022One Form 483, at Glen Rock, Pennsylvania.
Cited most
Across all Arx observations on file
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.192Production record review2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.160General requirements1
The complete Arx file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Glen Rock, Pennsylvania
Two Form 483s · 2019 to 2022 · 16 observations
Latest: Form 483, Jun 3, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-06-03 | 483 Form 483 | Glen Rock, Pennsylvania | 7 | $99 |
| 2019-03-29 | 483 Form 483 | Glen Rock, Pennsylvania | 9 | $99 |
Investigators on these documents
Alice S. Tsao (1)Ankur C. Patel (1)Craig D. Zagata (1)James Norman (1)Jessica S. Estriplet (1)Simone E. Pitts (1)Yvins Dezan (1)
FEI number 2528933 · most recent document Jun 3, 2022
About Arx, LLC
How many FDA Form 483s has Arx, LLC received?
FDA Intel has 2 Form 483s on file for Arx, LLC; the most recent is dated Jun 3, 2022.
When was Arx, LLC last inspected by FDA?
The most recent FDA inspection document on file for Arx, LLC is a Form 483 dated Jun 3, 2022, for the site in Glen Rock, Pennsylvania.
What did FDA cite at Arx, LLC?
The regulations cited most in the observations on file for Arx, LLC are 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 3 times; 21 CFR 211.192 (Production record review), 2 times.