JC World Bell
Form 483 issued November 19, 2024 · Hackensack, New Jersey
- Inspection
- Nov 18 – Nov 19, 2024
- Investigators
- Josh Renzo N. Ramilo· Tomika Crafter
- Observations
- 3
- Pages
- 4
- FEI number
- 3010951428
In short: On November 19, 2024, FDA issued a Form 483 with 3 observations to JC World Bell in Hackensack, New Jersey (FEI 3010951428) after an inspection that ran Nov 18 – Nov 19, 2024. The investigators were Josh Renzo N. Ramilo and Tomika Crafter. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Routine calibration ol 'automatic equipment is not performed according to a written program designed…
- 03
The responsibilities and procedures applicable to the quality…
This inspection in context
Josh Renzo N. Ramilo
6 documents · 2023–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New York.
The firmJC World Bell history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at JC World Bell?
FDA listed 3 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected JC World Bell?
Josh Renzo N. Ramilo and Tomika Crafter are named on this Form 483, for the inspection of Nov 18 – Nov 19, 2024. Each investigator has a profile showing what they cite most.
When was JC World Bell inspected by FDA?
The inspection ran Nov 18 – Nov 19, 2024, and the Form 483 is dated November 19, 2024.
How do I get the full Form 483 for JC World Bell?
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.