OMEZA LLC
Form 483 issued July 28, 2023 · Sarasota, Florida
- Inspection
- Jul 24 – Jul 28, 2023
- Investigators
- Kayla V. Sprague· Pamela N. Agaba
- Observations
- 6
- Pages
- 4
- FEI number
- 3019843904
In short: On July 28, 2023, FDA issued a Form 483 with 6 observations to OMEZA LLC in Sarasota, Florida (FEI 3019843904) after an inspection that ran Jul 24 – Jul 28, 2023. The investigators were Kayla V. Sprague and Pamela N. Agaba. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Buildings used in the manufacture, processing, packing or holding of ding products are not maintained in…
- 02
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
The written stability testing…
This inspection in context
Kayla V. Sprague
17 documents · 2020–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Florida.
The firmOMEZA LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.56(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OMEZA LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, laboratory controls and materials. The opening words of each observation are shown on this page.
Who inspected OMEZA LLC?
Kayla V. Sprague and Pamela N. Agaba are named on this Form 483, for the inspection of Jul 24 – Jul 28, 2023. Each investigator has a profile showing what they cite most.
When was OMEZA LLC inspected by FDA?
The inspection ran Jul 24 – Jul 28, 2023, and the Form 483 is dated July 28, 2023.
How do I get the full Form 483 for OMEZA 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.