Essential Pharmacy Compounding LLC
Form 483 issued July 27, 2017 · Omaha, Nebraska
- Inspection
- Jul 10, 2017
- Investigator
- Kellia N. Hicks
- Observations
- 3
- Pages
- 2
- FEI number
- 3003718003
In short: On July 27, 2017, FDA issued a Form 483 with 3 observations to Essential Pharmacy Compounding LLC in Omaha, Nebraska (FEI 3003718003) after an inspection that ran Jul 10, 2017. The investigator was Kellia N. Hicks. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment, materials, and/or supplies are not cleaned prior to initiating aseptic production after the…
- 02
Personnel engaged in aseptic processing failed to prevent cross-contamination on the working surface of the ISO…
- 03
Non-sterile disinfecting agents are used in the aseptic…
This inspection in context
Kellia N. Hicks
28 documents · 2017–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 3 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 Essential Pharmacy Compounding LLC?
Kellia N. Hicks is named on this Form 483, for the inspection of Jul 10, 2017. Each investigator has a profile showing what they cite most.
When was Essential Pharmacy Compounding LLC inspected by FDA?
The inspection ran Jul 10, 2017, and the Form 483 is dated July 27, 2017.
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.