FDA-Inspected Site

RC Outsourcing, LLC

6 FDA inspections are on record for RC Outsourcing, LLC in Lowellville, United States.

483· Form 483 issued

Lowellville, United States · Last updated August 15, 2026

Overview

  • 6 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-08-28.

At a glance

Inspections

6

Form 483s

5

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
18 Aug 2025 – 28 Aug 2025Human DrugsWLView 483 →
17 Sep 2024 – 27 Sep 2024Human Drugs483View 483 →
31 Aug 2022 – 23 Sep 2022Human Drugs483View 483 →
14 Jan 2019 – 8 Feb 2019Human DrugsClean
27 Mar 2017 – 31 Mar 2017Human DrugsWLView 483 →
25 Jan 2016 – 9 Feb 2016Human Drugs483View 483 →

Observations on record

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

28 Aug 2025
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Margaret M Annes

28 Aug 2025
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Margaret M Annes

28 Aug 2025
21 CFR 211.188

Prepared for each batch, include complete information

Cited by Margaret M Annes

28 Aug 2025
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by Margaret M Annes

28 Aug 2025
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Margaret M Annes

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 211.192Cited across public-safe Form 483 observations6x
21 CFR 211.113(b)Cited across public-safe Form 483 observations5x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations4x
21 CFR 211.160(b)Cited across public-safe Form 483 observations3x
21 CFR 211.167(a)Cited across public-safe Form 483 observations3x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations3x
21 CFR 211.68(a)Cited across public-safe Form 483 observations3x
21 CFR 211.28(a)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(a)Cited across public-safe Form 483 observations1x
21 CFR 211.42(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
FDCA 503B(a)(10)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind RC Outsourcing, LLC's 5 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