FDA-Inspected Site

ProRx LLC

2 FDA inspections are on record for ProRx LLC in Exton, United States.

483· Form 483 issued

Exton, United States · Last updated July 12, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-09-19.

At a glance

Inspections

2

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
9 Sep 2025 – 19 Sep 2025Human DrugsWLView 483 →
15 Jul 2024 – 2 Aug 2024Human DrugsWLView 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

19 Sep 2025
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Taichun Qin

19 Sep 2025
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Taichun Qin

19 Sep 2025
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Taichun Qin

19 Sep 2025
21 CFR 211.22(c)

Approve or reject procedures or specs

Cited by Taichun Qin

19 Sep 2025
21 CFR 211.42(c)(10)(iv)

Environmental Monitoring System

Cited by Taichun Qin

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations4x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations2x
FDCA 503B(a)(10)(A)Cited across public-safe Form 483 observations2x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(c)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.28(a)Cited across public-safe Form 483 observations1x
21 CFR 211.56(a)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x
FDCA 503B(b)(2)(A)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind ProRx LLC's 2 Form 483s

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat