Specialty Vision Lie
Form 483 issued December 19, 2024 · Ridgefield Park, New Jersey
- Inspection
- Dec 9 – Dec 19, 2024
- Investigator
- Esteban Beltran
- Observations
- 3
- Pages
- 4
- FEI number
- 3011271964
In short: On December 19, 2024, FDA issued a Form 483 with 3 observations to Specialty Vision Lie in Ridgefield Park, New Jersey (FEI 3011271964) after an inspection that ran Dec 9 – Dec 19, 2024. The investigator was Esteban Beltran. Most observations concern management controls and production & process controls.
At a glance
Management controls and production & process controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Quality system procedures and instructions…
- 02
Acceptance activities were not…
- 03
Procedures for rework of nonconforming product have…
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 Lie history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.20(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Specialty Vision Lie?
FDA listed 3 observations on this Form 483, mostly about management controls, production & process controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Specialty Vision Lie?
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 Lie 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 Lie?
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.