Eugia US Manufacturing LLC
Form 483 issued February 22, 2023 · East Windsor, New Jersey
- Inspection
- Feb 11 – Feb 22, 2023
- Investigators
- Daniel L. Zheng· James R. Birkenstamm· Ruben C. Quintana
- Observations
- 10
- Pages
- 11
- FEI number
- 3015534630
In short: On February 22, 2023, FDA issued a Form 483 with 10 observations to Eugia US Manufacturing LLC in East Windsor, New Jersey (FEI 3015534630) after an inspection that ran Feb 11 – Feb 22, 2023. The investigators were Daniel L. Zheng, James R. Birkenstamm, Ruben C. Quintana and Yoriann M. Cabrera Bartolomei. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
6 of 10 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (3×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no quality…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Buildings used in the manufacture, processing, packing, or holding of a diug product do not have…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Daniel L. Zheng
24 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmEugia US Manufacturing LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eugia US Manufacturing LLC?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Eugia US Manufacturing LLC?
Daniel L. Zheng, James R. Birkenstamm, Ruben C. Quintana and Yoriann M. Cabrera Bartolomei are named on this Form 483, for the inspection of Feb 11 – Feb 22, 2023. Each investigator has a profile showing what they cite most.
When was Eugia US Manufacturing LLC inspected by FDA?
The inspection ran Feb 11 – Feb 22, 2023, and the Form 483 is dated February 22, 2023.
How do I get the full Form 483 for Eugia US Manufacturing 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.