FDA Intel

Arx, LLC

Form 483 issued June 3, 2022 · Glen Rock, Pennsylvania

Inspection
May 23 – Jun 3, 2022
Investigators
Ankur C. Patel· Jessica S. Estriplet· Yvins Dezan
Observations
7
Pages
16
FEI number
2528933

In short: On June 3, 2022, FDA issued a Form 483 with 7 observations to Arx, LLC in Glen Rock, Pennsylvania (FEI 2528933) after an inspection that ran May 23 – Jun 3, 2022. The investigators were Ankur C. Patel, Jessica S. Estriplet and Yvins Dezan. Most observations concern facilities & equipment and quality system.

At a glance

Facilities & equipment and quality system account for 5 of 7 observations.

Facilities & equipment3
Quality system2
Production2

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.22(d)

    The responsibilities and procedures applicable to the quality control unit are not in…

  2. 02
    21 CFR 211.192

    Investigations of an unexplained discrepancy did not extend to other batches of the same drug product…

  3. 03
    21 CFR 211.67(a)

    Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…

  4. 04
    21 CFR 211.68(b)

    Appropriate controls are not exercised over computers or related systems to assure that changes in taster…

3 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Ankur C. Patel

9 documents · 2021–2026

Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.

The firm

Arx, LLC history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.22(d)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Arx, LLC?

FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.

Who inspected Arx, LLC?

Ankur C. Patel, Jessica S. Estriplet and Yvins Dezan are named on this Form 483, for the inspection of May 23 – Jun 3, 2022. Each investigator has a profile showing what they cite most.

When was Arx, LLC inspected by FDA?

The inspection ran May 23 – Jun 3, 2022, and the Form 483 is dated June 3, 2022.

How do I get the full Form 483 for Arx, LLC?

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