Fresenius Medical Care North America
Form 483 issued May 21, 2021 · Ogden, Utah
- Inspection
- May 19 – May 21, 2021
- Investigator
- Saied A. Asbagh
- Observations
- 1
- Pages
- 3
- FEI number
- 1713747
In short: On May 21, 2021, FDA issued a Form 483 with 1 observation to Fresenius Medical Care North America in Ogden, Utah (FEI 1713747) after an inspection that ran May 19 – May 21, 2021. The investigator was Saied A. Asbagh. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies do not include…
This inspection in context
Saied A. Asbagh
12 documents · 2016–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmFresenius Medical Care North America history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fresenius Medical Care North America?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Fresenius Medical Care North America?
Saied A. Asbagh is named on this Form 483, for the inspection of May 19 – May 21, 2021. Each investigator has a profile showing what they cite most.
When was Fresenius Medical Care North America inspected by FDA?
The inspection ran May 19 – May 21, 2021, and the Form 483 is dated May 21, 2021.
How do I get the full Form 483 for Fresenius Medical Care North America?
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.