Arx, LLC
Form 483 issued March 29, 2019 · Glen Rock, Pennsylvania
- Inspection
- Mar 26 – Mar 29, 2019
- Investigators
- Alice S. Tsao· Craig D. Zagata· James Norman
- Observations
- 9
- Pages
- 5
- FEI number
- 2528933
In short: On March 29, 2019, FDA issued a Form 483 with 9 observations to Arx, LLC in Glen Rock, Pennsylvania (FEI 2528933) after an inspection that ran Mar 26 – Mar 29, 2019. The investigators were Alice S. Tsao, Craig D. Zagata, James Norman and Simone E. Pitts. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 7 of 9 observations.
Most cited: 21 CFR 211.67 (2×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The sensitivity, specificity and reproducibility of test methods…
- 02
There is no written testing program designed to assess the stability…
- 03
All records of production associated with a batch of drug product were not maintained at least…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including…
This inspection in context
Alice S. Tsao
16 documents · 2011–2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmArx, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Arx, LLC?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Arx, LLC?
Alice S. Tsao, Craig D. Zagata, James Norman and Simone E. Pitts are named on this Form 483, for the inspection of Mar 26 – Mar 29, 2019. Each investigator has a profile showing what they cite most.
When was Arx, LLC inspected by FDA?
The inspection ran Mar 26 – Mar 29, 2019, and the Form 483 is dated March 29, 2019.
How do I get the full Form 483 for Arx, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.