FDA-Inspected Site

Rx Compounding Inc.

4 FDA inspections are on record for Rx Compounding Inc. in Indianapolis, United States.

483· Form 483 issued

Indianapolis, United States · Last updated July 10, 2026

Overview

  • 4 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2016-08-19.

At a glance

Inspections

4

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
8 Aug 2016 – 19 Aug 2016Human Drugs483On file
6 Aug 2014 – 21 Aug 2014Human Drugs483View 483 →
14 May 2013 – 15 May 2013Human DrugsClean
19 Mar 2013 – 21 Mar 2013Human Drugs483View 483 →

Observations on record

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

21 Aug 2014
21 CFR 211.42(c)(10)

Aseptic Processing Area

Cited by Larry K Austin

21 Aug 2014
21 CFR 211.42(c)(10)(iv)

Environmental Monitoring System

Cited by Larry K Austin

21 Aug 2014
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Larry K Austin

21 Aug 2014
21 CFR 211.165(a)

Testing and release for distribution

Cited by Larry K Austin

21 Aug 2014
21 CFR 211.166(a)

Lack of written stability program

Cited by Larry K Austin

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 observations2x
21 CFR 211.165(a)Cited across public-safe Form 483 observations2x
21 CFR 211.166(a)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations2x
21 CFR 211.165(b)Cited across public-safe Form 483 observations1x
21 CFR 211.167(a)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Rx Compounding Inc.'s 3 Form 483s

Source PDFs, verbatim observations, 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