Excelvision

Form 483 issued January 22, 2026 · Annonay, France

Inspection
Jan 12 – Jan 22, 2026
Observations
11
Pages
18
FEI number
3007058211

In short: On January 22, 2026, FDA issued a Form 483 with 11 observations to Excelvision in Annonay, Ardeche (FEI 3007058211) after an inspection that ran Jan 12 – Jan 22, 2026. The investigators were Justin A. Boyd, Karen A. Briggs and Khoa Nathan V. Tran. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Facilities & equipment and production account for 9 of 11 observations.

Facilities & equipment6
Production3
Quality system2

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01

    There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…

  2. 02

    Observation 2: scanned text, readable in the full document.

  3. 03

    Observation 3: scanned text, readable in the full document.

  4. 04

    Observation 4: scanned text, readable in the full document.

7 more observations

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

Get the full 483

This inspection in context

Questions about this 483

What did FDA find at Excelvision?

FDA listed 11 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.

Who inspected Excelvision?

Justin A. Boyd, Karen A. Briggs and Khoa Nathan V. Tran are named on this Form 483, for the inspection of Jan 12 – Jan 22, 2026. Each investigator has a profile showing what they cite most.

When was Excelvision inspected by FDA?

The inspection ran Jan 12 – Jan 22, 2026, and the Form 483 is dated January 22, 2026.

How do I get the full Form 483 for Excelvision?

Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.

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