FDA Intel

AbleNet

Form 483 issued July 8, 2024 · Roseville, Minnesota

Inspection
Jun 26 – Jul 8, 2024
Investigators
Alicia U. Jacobo· Tyler R. Courtney
Observations
8
Pages
7
FEI number
3001576173

In short: On July 8, 2024, FDA issued a Form 483 with 8 observations to AbleNet in Roseville, Minnesota (FEI 3001576173) after an inspection that ran Jun 26 – Jul 8, 2024. The investigators were Alicia U. Jacobo and Tyler R. Courtney. Most observations concern cAPA and management controls.

At a glance

CAPA and management controls account for 7 of 8 observations.

CAPA4
Management controls3
Production & process controls1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 820.100(a)

    Procedures for corrective and preventive action…

  2. 02
    21 CFR 820.198(a)

    Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…

  3. 03
    21 CFR 820.22

    Procedures for quality audits…

  4. 04
    21 CFR 820.20(c)

    Procedures for management review…

4 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Alicia U. Jacobo

4 documents · 2024–2026

Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in Minnesota.

The firm

AbleNet history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 820.100(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at AbleNet?

FDA listed 8 observations on this Form 483, mostly about cAPA, management controls and production & process controls. The opening words of each observation are shown on this page.

Who inspected AbleNet?

Alicia U. Jacobo and Tyler R. Courtney are named on this Form 483, for the inspection of Jun 26 – Jul 8, 2024. Each investigator has a profile showing what they cite most.

When was AbleNet inspected by FDA?

The inspection ran Jun 26 – Jul 8, 2024, and the Form 483 is dated July 8, 2024.

How do I get the full Form 483 for AbleNet?

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