FDA Intel

RC Outsourcing LLC

Form 483 issued February 9, 2016 · Ohio

Inspection
Jan 27 – Feb 9, 2016
Investigator
Joshua P. Wireman
Observations
8
Pages
6
FEI number
3011967886

In short: On February 9, 2016, FDA issued a Form 483 with 8 observations to RC Outsourcing LLC in Ohio (FEI 3011967886) after an inspection that ran Jan 27 – Feb 9, 2016. The investigator was Joshua P. Wireman. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Observations span 4 systems, led by facilities & equipment.

Facilities & equipment3
Laboratory controls1
Production1
Quality system1
Other2

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.167(a)

    Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…

  2. 02
    21 CFR 211.113(b)

    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile…

  3. 03
    21 CFR 211.42(c)(10)(iv)

    Aseptic processing areas are deficient regarding the system…

  4. 04
    21 CFR 211.192

    There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…

4 more observations

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

Get the full 483

This inspection in context

The investigator

Joshua P. Wireman

8 documents · 2015–2019

Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.

The firm

RC Outsourcing LLC history

All 9 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.167(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at RC Outsourcing LLC?

FDA listed 8 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.

Who inspected RC Outsourcing LLC?

Joshua P. Wireman is named on this Form 483, for the inspection of Jan 27 – Feb 9, 2016. Each investigator has a profile showing what they cite most.

When was RC Outsourcing LLC inspected by FDA?

The inspection ran Jan 27 – Feb 9, 2016, and the Form 483 is dated February 9, 2016.

How do I get the full Form 483 for RC Outsourcing LLC?

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