FDA Intel

Inman Orthodontic Laboratories, Inc

Form 483 issued December 18, 2024 · Coral Springs, Florida

Inspection
Dec 11 – Dec 18, 2024
Investigator
David M. Wilkinson
Observations
10
Pages
10
FEI number
3005663102

In short: On December 18, 2024, FDA issued a Form 483 with 10 observations to Inman Orthodontic Laboratories, Inc in Coral Springs, Florida (FEI 3005663102) after an inspection that ran Dec 11 – Dec 18, 2024. The investigator was David M. Wilkinson. Most observations concern management controls and cAPA.

At a glance

Management controls and capa account for 6 of 10 observations.

Management controls3
CAPA3
Records & documents2
Design controls1
Other1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 820.22

    Procedures for quality audits…

  2. 02
    21 CFR 820.25(b)

    Procediues for training and identifying training needs…

  3. 03
    21 CFR 820.100(a)

    Procedmes for corrective and preventive action…

  4. 04
    21 CFR 820.30(a)

    Procedmes for design control…

6 more observations

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

Get the full 483

This inspection in context

The investigator

David M. Wilkinson

7 documents · 2018–2025

Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Florida.

The firm

Inman Orthodontic Laboratories, Inc history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 820.22

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Inman Orthodontic Laboratories, Inc?

FDA listed 10 observations on this Form 483, mostly about management controls, cAPA and records & documents. The opening words of each observation are shown on this page.

Who inspected Inman Orthodontic Laboratories, Inc?

David M. Wilkinson is named on this Form 483, for the inspection of Dec 11 – Dec 18, 2024. Each investigator has a profile showing what they cite most.

When was Inman Orthodontic Laboratories, Inc inspected by FDA?

The inspection ran Dec 11 – Dec 18, 2024, and the Form 483 is dated December 18, 2024.

How do I get the full Form 483 for Inman Orthodontic Laboratories, Inc?

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