Essential Pharmacy Compounding LLC
Form 483 issued July 23, 2015 · Omaha, Nebraska
- Inspection
- May 13, 2020
- Investigators
- Eric M. Mueller· Jenny Agila Sefen· Joseph R. Lambert
- Observations
- 12
- Pages
- 7
- FEI number
- 3003718003
In short: On July 23, 2015, FDA issued a Form 483 with 12 observations to Essential Pharmacy Compounding LLC in Omaha, Nebraska (FEI 3003718003) after an inspection that ran May 13, 2020. The investigators were Eric M. Mueller, Jenny Agila Sefen and Joseph R. Lambert. Most observations concern facilities & equipment and quality system.
At a glance
Observations span 4 systems, led by facilities & equipment.
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 sterile do not include…
- 02
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
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 firmEssential Pharmacy Compounding LLC history
All 4 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 Essential Pharmacy Compounding LLC?
FDA listed 12 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Essential Pharmacy Compounding LLC?
Eric M. Mueller, Jenny Agila Sefen and Joseph R. Lambert are named on this Form 483, for the inspection of May 13, 2020. Each investigator has a profile showing what they cite most.
When was Essential Pharmacy Compounding LLC inspected by FDA?
The inspection ran May 13, 2020, and the Form 483 is dated July 23, 2015.
How do I get the full Form 483 for Essential Pharmacy Compounding LLC?
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.