Hovione LLC
Form 483 issued November 17, 2022 · East Windsor, New Jersey
- Inspection
- Nov 14 – Nov 17, 2022
- Investigators
- Adetutu Gidado· Robin P. Mathew
- Observations
- 1
- Pages
- 2
- FEI number
- 3006106736
In short: On November 17, 2022, FDA issued a Form 483 with 1 observation to Hovione LLC in East Windsor, New Jersey (FEI 3006106736) after an inspection that ran Nov 14 – Nov 17, 2022. The investigators were Adetutu Gidado and Robin P. Mathew. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Routine calibration of mechanical equipment is not performed according to a written program designed…
This inspection in context
Adetutu Gidado
16 documents · 2016–2025
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The firmHovione LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hovione LLC?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Hovione LLC?
Adetutu Gidado and Robin P. Mathew are named on this Form 483, for the inspection of Nov 14 – Nov 17, 2022. Each investigator has a profile showing what they cite most.
When was Hovione LLC inspected by FDA?
The inspection ran Nov 14 – Nov 17, 2022, and the Form 483 is dated November 17, 2022.
How do I get the full Form 483 for Hovione 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.