Hennepin Healthcare System, Inc.

483 response sent May 17, 2019 · Minneapolis, Minnesota

Inspection: Apr 10 – Apr 26, 2019
Investigator: Kellie L. Thommes
Pages: 24
FEI number: 3015212514

In short: This is Hennepin Healthcare System, Inc.'s written response to FDA, dated May 17, 2019, for its site in Minneapolis, Minnesota (FEI 3015212514). It sets out the corrective actions the firm committed to.

Inside this response

The full response

Every page of the response, exactly as written.

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This inspection in context

The investigator

Kellie L. Thommes

4 documents · 2018–2025

Cites 50.23 (exception from general requirements) more than any other section. Most of their documents are for sites in Minnesota.

The firm

Hennepin Healthcare System, Inc. history

All 3 documents on file for this site, in date order, with what was cited at each inspection.

Questions about this response

Who inspected Hennepin Healthcare System, Inc.?

Kellie L. Thommes is named on this 483 response, for the inspection of Apr 10 – Apr 26, 2019. Each investigator has a profile showing what they cite most.

When was Hennepin Healthcare System, Inc. inspected by FDA?

The inspection ran Apr 10 – Apr 26, 2019, and the 483 response is dated May 17, 2019.

How do I get the full 483 response for Hennepin Healthcare System, Inc.?

Download the original PDF from FDA Intel for $199, with no subscription. You also get an invoice PDF with the order.