Excelvision
Form 483 issued November 19, 2024 · Annonay, France
- Inspection
- Nov 12 – Nov 19, 2024
- Investigators
- Angelica M. Hernandez· Eileen A. Liu
- Observations
- 5
- Pages
- 6
- FEI number
- 3007058211
In short: On November 19, 2024, FDA issued a Form 483 with 5 observations to Excelvision in Annonay, France (FEI 3007058211) after an inspection that ran Nov 12 – Nov 19, 2024. The investigators were Angelica M. Hernandez and Eileen A. Liu. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and quality system account for 3 of 5 observations.
Most cited: 21 CFR 211.113 (2×)
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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
This inspection in context
Angelica M. Hernandez
15 documents · 2022–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.113
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 production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Excelvision?
Angelica M. Hernandez and Eileen A. Liu are named on this Form 483, for the inspection of Nov 12 – Nov 19, 2024. Each investigator has a profile showing what they cite most.
When was Excelvision inspected by FDA?
The inspection ran Nov 12 – Nov 19, 2024, and the Form 483 is dated November 19, 2024.
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.