Salvona Technologies, LLC
Form 483 issued October 18, 2024 · Hamilton, New Jersey
- Inspection
- Oct 3 – Oct 18, 2024
- Investigators
- Jenny Sung· Rose Jean-Mary· Suchan Kim
- Observations
- 8
- Pages
- 8
- FEI number
- 3009344346
In short: On October 18, 2024, FDA issued a Form 483 with 8 observations to Salvona Technologies, LLC in Hamilton, New Jersey (FEI 3009344346) after an inspection that ran Oct 3 – Oct 18, 2024. The investigators were Jenny Sung, Rose Jean-Mary and Suchan Kim. Most observations concern facilities & equipment and laboratory controls.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish adequate written procedmes for production and process controls designed to assure…
- 02
Routine checking of equipment is not performed according to a written program designed…
- 03
There is no written testing program designed to assess the stability…
- 04
Written proceduires are not established for the clean ing and ma intenance of equipment, inc•hiding utensils…
This inspection in context
Jenny Sung
4 documents · 2004–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmSalvona Technologies, LLC 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 Salvona Technologies, LLC?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Salvona Technologies, LLC?
Jenny Sung, Rose Jean-Mary and Suchan Kim are named on this Form 483, for the inspection of Oct 3 – Oct 18, 2024. Each investigator has a profile showing what they cite most.
When was Salvona Technologies, LLC inspected by FDA?
The inspection ran Oct 3 – Oct 18, 2024, and the Form 483 is dated October 18, 2024.
How do I get the full Form 483 for Salvona Technologies, 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.