Sentara Enterprises
Form 483 issued July 23, 2015 · Chesapeake, Virginia
- Inspection
- Jul 13 – Jul 23, 2015
- Investigator
- Wilfred A. Darang
- Observations
- 11
- Pages
- 6
- FEI number
- 3011627411
In short: On July 23, 2015, FDA issued a Form 483 with 11 observations to Sentara Enterprises in Chesapeake, Virginia (FEI 3011627411) after an inspection that ran Jul 13 – Jul 23, 2015. The investigator was Wilfred A. Darang. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 7 of 11 observations.
Most cited: 21 CFR 211.42 (3×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for…
- 04
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
This inspection in context
Wilfred A. Darang
2 documents · 2015
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Virginia.
The firmSentara Enterprises history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sentara Enterprises?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Sentara Enterprises?
Wilfred A. Darang is named on this Form 483, 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 Form 483 is dated July 23, 2015.
How do I get the full Form 483 for Sentara Enterprises?
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.