Biomerics IMP Mebane LLC
Form 483 issued October 18, 2024 · Mebane, North Carolina
- Inspection
- Oct 15 – Oct 18, 2024
- Investigators
- Christopher B. May· Lashawn M. Elam
- Observations
- 3
- Pages
- 4
- FEI number
- 1000140478
In short: On October 18, 2024, FDA issued a Form 483 with 3 observations to Biomerics IMP Mebane LLC in Mebane, North Carolina (FEI 1000140478) after an inspection that ran Oct 15 – Oct 18, 2024. The investigators were Christopher B. May and Lashawn M. Elam. Most observations concern cAPA and production & process controls.
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Collective and preventive action activities and/or results have…
- 02
Procediues for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
Schedules for the adjustment, cleaning, and other maintenance of equipment have…
This inspection in context
Christopher B. May
4 documents · 2022–2024
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in North Carolina.
The firmBiomerics IMP Mebane LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biomerics IMP Mebane LLC?
FDA listed 3 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Biomerics IMP Mebane LLC?
Christopher B. May and Lashawn M. Elam are named on this Form 483, for the inspection of Oct 15 – Oct 18, 2024. Each investigator has a profile showing what they cite most.
When was Biomerics IMP Mebane LLC inspected by FDA?
The inspection ran Oct 15 – Oct 18, 2024, and the Form 483 is dated October 18, 2024.
How do I get the full Form 483 for Biomerics IMP Mebane LLC?
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