Sentara Enterprises

483 response sent August 12, 2015 · Chesapeake, Virginia

Inspection: Jul 13 – Jul 23, 2015
Investigators: Nebil A. Oumer· Wilfred A. Darang
Pages: 10
FEI number: 3011627411

In short: This is Sentara Enterprises's written response to FDA, dated August 12, 2015, for its site in Chesapeake, Virginia (FEI 3011627411). 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

Nebil A. Oumer

5 documents · 2012–2015

Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Virginia.

The firm

Sentara Enterprises history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Questions about this response

Who inspected Sentara Enterprises?

Nebil A. Oumer and Wilfred A. Darang are named on this 483 response, for the inspection of Jul 13 – Jul 23, 2015. Each investigator has a profile showing what they cite most.

When was Sentara Enterprises inspected by FDA?

The inspection ran Jul 13 – Jul 23, 2015, and the 483 response is dated August 12, 2015.

How do I get the full 483 response for Sentara Enterprises?

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