Duralife-USA, LLC
Form 483 issued February 7, 2017 · South Williamsport, Pennsylvania
- Inspection
- Jan 25 – Feb 7, 2017
- Investigator
- Brandi L. Garbutt
- Observations
- 3
- Pages
- 3
In short: On February 7, 2017, FDA issued a Form 483 with 3 observations to Duralife-USA, LLC in South Williamsport, Pennsylvania after an inspection that ran Jan 25 – Feb 7, 2017. The investigator was Brandi L. Garbutt. Most observations concern cAPA and management controls.
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written MDR procedures have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 03
Quality system procedures and instructions…
This inspection in context
Brandi L. Garbutt
10 documents · 2010–2017
Cites 118.4(b)(3) (salmonella enteritidis (se) prevention measures) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmDuralife-USA, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Duralife-USA, LLC?
FDA listed 3 observations on this Form 483, mostly about cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Duralife-USA, LLC?
Brandi L. Garbutt is named on this Form 483, for the inspection of Jan 25 – Feb 7, 2017. Each investigator has a profile showing what they cite most.
When was Duralife-USA, LLC inspected by FDA?
The inspection ran Jan 25 – Feb 7, 2017, and the Form 483 is dated February 7, 2017.
How do I get the full Form 483 for Duralife-USA, LLC?
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.