Excelvision
Form 483 issued July 7, 2023 · ANNONAY, France
- Inspection
- Jun 29 – Jul 7, 2023
- Investigator
- Jeffrey P. Raimondi
- Observations
- 5
- Pages
- 6
- FEI number
- 3007058211
In short: On July 7, 2023, FDA issued a Form 483 with 5 observations to Excelvision in ANNONAY, France (FEI 3007058211) after an inspection that ran Jun 29 – Jul 7, 2023. The investigator was Jeffrey P. Raimondi. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Jeffrey P. Raimondi
40 documents · 2017–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmExcelvision history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Excelvision?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and production. 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?
Jeffrey P. Raimondi is named on this Form 483, for the inspection of Jun 29 – Jul 7, 2023. Each investigator has a profile showing what they cite most.
When was Excelvision inspected by FDA?
The inspection ran Jun 29 – Jul 7, 2023, and the Form 483 is dated July 7, 2023.
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.