Navinta LLC
Form 483 issued June 29, 2023 · Ewing, New Jersey
- Inspection
- Jun 20 – Jun 29, 2023
- Investigator
- Frank J. Marciniak
- Observations
- 5
- Pages
- 5
- FEI number
- 3004375014
In short: On June 29, 2023, FDA issued a Form 483 with 5 observations to Navinta LLC in Ewing, New Jersey (FEI 3004375014) after an inspection that ran Jun 20 – Jun 29, 2023. The investigator was Frank J. Marciniak. Most observations concern production & process controls and design controls.
At a glance
Production & process controls and design controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Requirements that must be met by suppliers and contractors have…
- 02
Procedures for design control have not been…
- 03
Procedures for quality audits have…
- 04
Procedures for corrective and preventive action have…
This inspection in context
Frank J. Marciniak
7 documents · 2018–2023
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmNavinta LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Navinta LLC?
FDA listed 5 observations on this Form 483, mostly about production & process controls, design controls and management controls. The opening words of each observation are shown on this page.
Who inspected Navinta LLC?
Frank J. Marciniak is named on this Form 483, for the inspection of Jun 20 – Jun 29, 2023. Each investigator has a profile showing what they cite most.
When was Navinta LLC inspected by FDA?
The inspection ran Jun 20 – Jun 29, 2023, and the Form 483 is dated June 29, 2023.
How do I get the full Form 483 for Navinta 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.