Hovione LLC
Form 483 issued January 22, 2020 · East Windsor, New Jersey
- Inspection
- Jan 13 – Jan 22, 2020
- Investigator
- Adetutu Gidado
- Observations
- 2
- Pages
- 3
- FEI number
- 3006106736
In short: On January 22, 2020, FDA issued a Form 483 with 2 observations to Hovione LLC in East Windsor, New Jersey (FEI 3006106736) after an inspection that ran Jan 13 – Jan 22, 2020. The investigator was Adetutu Gidado. Most observations concern quality system; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.25 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Employees engaged in the manufacture and analytical testing of Intermediates and finished Active Pharmaceutical Ingredients lack…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or…
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 211.25
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hovione LLC?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected Hovione LLC?
Adetutu Gidado is named on this Form 483, for the inspection of Jan 13 – Jan 22, 2020. Each investigator has a profile showing what they cite most.
When was Hovione LLC inspected by FDA?
The inspection ran Jan 13 – Jan 22, 2020, and the Form 483 is dated January 22, 2020.
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.