SAFC Inc
Form 483 issued April 25, 2014 · Madison, Wisconsin
- Inspection
- Apr 17 – Apr 25, 2014
- Investigator
- Corey K. Reno
- Observations
- 3
- Pages
- 2
- FEI number
- 2131129
In short: On April 25, 2014, FDA issued a Form 483 with 3 observations to SAFC Inc in Madison, Wisconsin (FEI 2131129) after an inspection that ran Apr 17 – Apr 25, 2014. The investigator was Corey K. Reno. Most observations concern cAPA and production & process 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
Schedules for the adjustment, cleaning, and other maintenance of equipment have…
- 02
Products that do not conform to specifications…
- 03
Procedures for corrective and preventive action have…
This inspection in context
Corey K. Reno
2 documents · 2014–2015
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Wisconsin.
The firmSAFC Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.70
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SAFC Inc?
FDA listed 3 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected SAFC Inc?
Corey K. Reno is named on this Form 483, for the inspection of Apr 17 – Apr 25, 2014. Each investigator has a profile showing what they cite most.
When was SAFC Inc inspected by FDA?
The inspection ran Apr 17 – Apr 25, 2014, and the Form 483 is dated April 25, 2014.
How do I get the full Form 483 for SAFC 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.