Specialty Vision Llc
Form 483 issued December 19, 2024 · Ridgefield Park, New Jersey
- Inspection
- Dec 9 – Dec 19, 2024
- Investigator
- Esteban Beltran
- Observations
- 1
- Pages
- 4
In short: On December 19, 2024, FDA issued a Form 483 with 1 observation to Specialty Vision Llc in Ridgefield Park, New Jersey after an inspection that ran Dec 9 – Dec 19, 2024. The investigator was Esteban Beltran. Most observations concern management controls; the most-cited regulation is 21 CFR 820.20 (management responsibility).
At a glance
1 of 1 observations on this 483 concern management controls.
Most cited: 21 CFR 820.20 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Quality system procedures and instructions…
This inspection in context
Esteban Beltran
9 documents · 2017–2025
Cites 820.70(a) (production and process controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmSpecialty Vision Llc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.20
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Specialty Vision Llc?
FDA listed 1 observation on this Form 483, mostly about management controls. The most-cited regulation is 21 CFR 820.20 (management responsibility). The opening words of each observation are shown on this page.
Who inspected Specialty Vision Llc?
Esteban Beltran is named on this Form 483, for the inspection of Dec 9 – Dec 19, 2024. Each investigator has a profile showing what they cite most.
When was Specialty Vision Llc inspected by FDA?
The inspection ran Dec 9 – Dec 19, 2024, and the Form 483 is dated December 19, 2024.
How do I get the full Form 483 for Specialty Vision Llc?
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.