Sentara Enterprises
Form 483 issued August 6, 2018 · Chesapeake, Virginia
- Inspection
- Aug 6, 2018
- Investigator
- Mindy M. Chou
- Observations
- 8
- Pages
- 4
- FEI number
- 3011627411
In short: On August 6, 2018, FDA issued a Form 483 with 8 observations to Sentara Enterprises in Chesapeake, Virginia (FEI 3011627411) after an inspection that ran Aug 6, 2018. The investigator was Mindy M. Chou. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
5 of 8 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (4×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the processing of drug products are not maintained in a…
- 02
Your facility design allowed the influx of poor quality air into…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Cleaning pads or wipes used in the ISO 5 aseptic processing…
This inspection in context
Mindy M. Chou
37 documents · 2015–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New York.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sentara Enterprises?
FDA listed 8 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Sentara Enterprises?
Mindy M. Chou is named on this Form 483, for the inspection of Aug 6, 2018. Each investigator has a profile showing what they cite most.
When was Sentara Enterprises inspected by FDA?
The inspection ran Aug 6, 2018, and the Form 483 is dated August 6, 2018.
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.