Vils Pharma Coating, LLC
Form 483 issued November 21, 2024 · Edison, New Jersey
- Inspection
- Nov 15 – Nov 21, 2024
- Investigators
- Claude Noel Y. Zanetsie· Rose Jean-Mary
- Observations
- 4
- Pages
- 5
- FEI number
- 3000718444
In short: On November 21, 2024, FDA issued a Form 483 with 4 observations to Vils Pharma Coating, LLC in Edison, New Jersey (FEI 3000718444) after an inspection that ran Nov 15 – Nov 21, 2024. The investigators were Claude Noel Y. Zanetsie and Rose Jean-Mary. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Routine checking of equipmen t is not performed according to a written prog ram designed…
- 02
Equipment and utensils are no cleaned, m?tintained and sanitized at appropn ate intervals to prevent malfunctions…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Claude Noel Y. Zanetsie
3 documents · 2004–2025
Cites 211.194 (laboratory records) more than any other section. Most of their documents are for sites in New Jersey.
The firmVils Pharma Coating, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vils Pharma Coating, LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Vils Pharma Coating, LLC?
Claude Noel Y. Zanetsie and Rose Jean-Mary are named on this Form 483, for the inspection of Nov 15 – Nov 21, 2024. Each investigator has a profile showing what they cite most.
When was Vils Pharma Coating, LLC inspected by FDA?
The inspection ran Nov 15 – Nov 21, 2024, and the Form 483 is dated November 21, 2024.
How do I get the full Form 483 for Vils Pharma Coating, LLC?
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