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FDA Inspection
•Biomerics IMP Mebane LLC•October 18, 2024

Biomerics IMP Mebane LLC – FDA Inspection, Oct 18, 2024

Record Details

This FDA Inspection record concerns Biomerics IMP Mebane LLC, with an inspection on October 18, 2024, issued by the Atlanta District Office, covering medical devices & rad health.

Company
Biomerics IMP Mebane LLC
Inspection Date
October 18, 2024
Product Type
Medical Devices & Rad Health
Office
Atlanta District Office
People
  • Christopher B. May (Investigator)
  • Lashawn M. Elam (Investigator)
View Company Profile

ID · ca01d5c1-1773-461b-8926-95ba81ae1d71

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1252012
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Medical Devices
Outcome
Form 483 issued, view the record

FDA Citations

3
  1. 21 CFR 820.100(b)Documentation
  2. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  3. 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule

Full citation text and observation details available on the Dashboard.

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