FDA-Inspected Site

BTE Technologies, LLC

5 FDA inspections are on record for BTE Technologies, LLC in Hanover, United States.

Clean· No action indicated

Hanover, United States · Last updated August 15, 2026

Overview

  • 5 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-06-29.

At a glance

Inspections

5

Form 483s

4

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
25 Jun 2026 – 29 Jun 2026Medical Devices & Rad HealthClean
28 Jan 2020 – 31 Jan 2020Medical Devices & Rad Health483View 483 →
17 Feb 2016 – 26 Feb 2016Medical Devices & Rad Health483View 483 →
13 May 2013 – 5 Jun 2013Medical Devices & Rad Health483View 483 →
25 May 2012Not recorded483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

31 Jan 2020
21 CFR 820.30(e)

Design review - Lack of or inadequate procedures

Cited by Jude C Dike

31 Jan 2020
21 CFR 820.30(e)

Design review - Lack of or inadequate procedures

Cited by Jude C Dike

31 Jan 2020
21 CFR 820.90(a)

Nonconforming product, Lack of or inadequate procedures

Cited by Jude C Dike

31 Jan 2020
21 CFR 820.90(a)

Nonconforming product, Lack of or inadequate procedures

Cited by Jude C Dike

26 Feb 2016
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Erin L Mcfiren, Erin L Sisler

Investigators

FDA investigators tied to this site in the record.

Andrea D Gomez1 insp.
Erin L Sisler1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations3x
21 CFR 820.90(a)Cited across public-safe Form 483 observations3x
21 CFR 820.100(b)Cited across public-safe Form 483 observations2x
21 CFR 820.25(b)Cited across public-safe Form 483 observations2x
21 CFR 820.30(e)Cited across public-safe Form 483 observations2x
21 CFR 820.50(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 806.10(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(d)Cited across public-safe Form 483 observations1x
21 CFR 820.20(c)Cited across public-safe Form 483 observations1x
21 CFR 820.30(a)Cited across public-safe Form 483 observations1x
21 CFR 820.50(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind BTE Technologies, LLC's 4 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat