Staubach Barror Water Systems Inc., DBA
Form 483 issued January 8, 2016 · Schenectady, New York
- Inspection
- Dec 21, 2015 – Jan 8, 2016
- Investigator
- Scott R. Izyk
- Observations
- 6
- Pages
- 4
- FEI number
- 3006426779
In short: On January 8, 2016, FDA issued a Form 483 with 6 observations to Staubach Barror Water Systems Inc., DBA in Schenectady, New York (FEI 3006426779) after an inspection that ran Dec 21, 2015 – Jan 8, 2016. The investigator was Scott R. Izyk. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for acceptance of incoming product have…
- 02
Document control procedures have…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 04
Procedures for corrective and preventive action have…
This inspection in context
Scott R. Izyk
5 documents · 2015–2016
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in New York.
The firmStaubach Barror Water Systems Inc., DBA history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.80(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Staubach Barror Water Systems Inc., DBA?
FDA listed 6 observations on this Form 483, mostly about production & process controls, cAPA and records & documents. The opening words of each observation are shown on this page.
Who inspected Staubach Barror Water Systems Inc., DBA?
Scott R. Izyk is named on this Form 483, for the inspection of Dec 21, 2015 – Jan 8, 2016. Each investigator has a profile showing what they cite most.
When was Staubach Barror Water Systems Inc., DBA inspected by FDA?
The inspection ran Dec 21, 2015 – Jan 8, 2016, and the Form 483 is dated January 8, 2016.
How do I get the full Form 483 for Staubach Barror Water Systems Inc., DBA?
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.