Nebraska Methodist Hospital
Form 483 issued July 14, 2014 · Omaha, Nebraska
- Inspection
- Jun 24 – Jul 14, 2014
- Investigator
- Eric M. Mueller
- Observations
- 6
- Pages
- 3
- FEI number
- 1000511010
In short: On July 14, 2014, FDA issued a Form 483 with 6 observations to Nebraska Methodist Hospital in Omaha, Nebraska (FEI 1000511010) after an inspection that ran Jun 24 – Jul 14, 2014. The investigator was Eric M. Mueller. 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 4 of 6 observations.
Most cited: 21 CFR 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
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 02
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. You have failed to…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
- 04
Clothing of personnel engaged in the manufacturing, processing, packing, and holding of drug products is not…
This inspection in context
Eric M. Mueller
6 documents · 2009–2015
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Nebraska.
The firmNebraska Methodist Hospital history
All 3 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 Nebraska Methodist Hospital?
FDA listed 6 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 Nebraska Methodist Hospital?
Eric M. Mueller is named on this Form 483, for the inspection of Jun 24 – Jul 14, 2014. Each investigator has a profile showing what they cite most.
When was Nebraska Methodist Hospital inspected by FDA?
The inspection ran Jun 24 – Jul 14, 2014, and the Form 483 is dated July 14, 2014.
How do I get the full Form 483 for Nebraska Methodist Hospital?
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.