Sterilization Services Of Virginia, Inc

Form 483 issued May 6, 2015 · Richmond, Virginia

Inspection
May 4 – May 6, 2015
Investigator
Marc S. Neubauer
Observations
2
Pages
3
FEI number
1000123180

In short: On May 6, 2015, FDA issued a Form 483 with 2 observations to Sterilization Services Of Virginia, Inc in Richmond, Virginia (FEI 1000123180) after an inspection that ran May 4 – May 6, 2015. The investigator was Marc S. Neubauer. Most observations concern cAPA and management controls; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).

At a glance

CAPA and management controls account for 2 of 2 observations.

CAPA1
Management controls1

Most cited: 21 CFR 820.100(a) (1×) · 820.22 (1×)

What FDA observed

Preview: the opening words of each observation
  1. 01

    Procedures for corrective and preventive action have…

  2. 02

    Individuals who conduct quality audits have direct responsibility for…

The full 483

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This inspection in context

Questions about this 483

What did FDA find at Sterilization Services Of Virginia, Inc?

FDA listed 2 observations on this Form 483, mostly about cAPA and management controls. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.

Who inspected Sterilization Services Of Virginia, Inc?

Marc S. Neubauer is named on this Form 483, for the inspection of May 4 – May 6, 2015. Each investigator has a profile showing what they cite most.

When was Sterilization Services Of Virginia, Inc inspected by FDA?

The inspection ran May 4 – May 6, 2015, and the Form 483 is dated May 6, 2015.

How do I get the full Form 483 for Sterilization Services Of Virginia, Inc?

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