Fresenius USA Manufacturing, Inc
Form 483 issued June 26, 2020 · Knoxville, Tennessee
- Inspection
- Jun 22 – Jun 26, 2020
- Investigator
- Margaret M. Annes
- Observations
- 1
- Pages
- 3
- FEI number
- 3013546115
In short: On June 26, 2020, FDA issued a Form 483 with 1 observation to Fresenius USA Manufacturing, Inc in Knoxville, Tennessee (FEI 3013546115) after an inspection that ran Jun 22 – Jun 26, 2020. The investigator was Margaret M. Annes. The most-cited regulation is 21 CFR 314.81 (other postmarketing reports).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmFresenius USA Manufacturing, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 314.81
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fresenius USA Manufacturing, Inc?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 314.81 (other postmarketing reports). The opening words of each observation are shown on this page.
Who inspected Fresenius USA Manufacturing, Inc?
Margaret M. Annes is named on this Form 483, for the inspection of Jun 22 – Jun 26, 2020. Each investigator has a profile showing what they cite most.
When was Fresenius USA Manufacturing, Inc inspected by FDA?
The inspection ran Jun 22 – Jun 26, 2020, and the Form 483 is dated June 26, 2020.
How do I get the full Form 483 for Fresenius USA Manufacturing, 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.