Excelvision

Warning letter 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 sent a warning letter to Excelvision in Annonay, France (FEI 3007058211). 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

Most cited: 21 CFR 211.113(b) (2×)

What the letter cites

Preview: the opening words of each observation
  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 warning letter

This inspection in context

Questions about this warning letter

Who inspected Excelvision?

Justin A. Boyd, Karen A. Briggs and Khoa Nathan V. Tran are named on this Warning letter, 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 Warning letter is dated January 22, 2026.

How do I get the full Warning letter for Excelvision?

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