FDA-Inspected Site

Akervall Technologies, Inc.

1 FDA inspection is on record for Akervall Technologies, Inc. in Saline, United States.

483· Form 483 issued

Saline, United States · Last updated August 15, 2026

Overview

  • 1 FDA inspection is on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2025-11-06.

At a glance

Inspections

1

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
3 Nov 2025 – 6 Nov 2025Medical Devices & Rad Health483View 483 →

Observations on record

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

6 Nov 2025
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Felicia E Armbrustmacher

6 Nov 2025
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Felicia E Armbrustmacher

6 Nov 2025
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Felicia E Armbrustmacher

6 Nov 2025
21 CFR 820.25(b)

Training - Lack of or inadequate procedures

Cited by Felicia E Armbrustmacher

6 Nov 2025
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Felicia E Armbrustmacher

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.25(b)Cited across public-safe Form 483 observations1x
21 CFR 820.30(i)Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x
21 CFR 820.70(g)Cited across public-safe Form 483 observations1x
21 CFR 820.72(a)Cited across public-safe Form 483 observations1x
21 CFR 820.80(c)Cited across public-safe Form 483 observations1x
21 CFR 820.90(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Akervall Technologies, Inc.'s 1 Form 483

Source PDFs 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