Hovione LLC
Form 483 issued May 28, 2021 · East Windsor, New Jersey
- Inspection
- May 28, 2021
- Investigators
- Annet R. Rajan· Robin P. Mathew· Saleem A. Akhtar
- Observations
- 8
- Pages
- 23
- FEI number
- 3006106736
In short: On May 28, 2021, FDA issued a Form 483 with 8 observations to Hovione LLC in East Windsor, New Jersey (FEI 3006106736) after an inspection that ran May 28, 2021. The investigators were Annet R. Rajan, Robin P. Mathew, Saleem A. Akhtar and Stelios C. Tsinontides. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.80 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the…
- 02
Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of…
- 03
Laboratory records are deficient in that they do not include a complete record of all…
- 04
Written production and process control procedures are not followed in the execution of production and process…
This inspection in context
Annet R. Rajan
16 documents · 2020–2026
Cites 211.192 (production record review) 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 211.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hovione LLC?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, quality system and materials. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected Hovione LLC?
Annet R. Rajan, Robin P. Mathew, Saleem A. Akhtar and Stelios C. Tsinontides are named on this Form 483, for the inspection of May 28, 2021. Each investigator has a profile showing what they cite most.
When was Hovione LLC inspected by FDA?
The inspection ran May 28, 2021, and the Form 483 is dated May 28, 2021.
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.