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.
Most cited: 21 CFR 820.100(a) (1×) · 820.22 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Individuals who conduct quality audits have direct responsibility for…
This inspection in context
Marc S. Neubauer
3 documents · 2011–2017
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Maryland.
The firmSterilization Services Of Virginia, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
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?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.