Atlas

FDA-Inspected Site

Navinta LLC

8 FDA inspections are on record for Navinta LLC in Ewing, United States.

Clean· No action indicated

Ewing, United States · Last updated August 15, 2026

Overview

  • 8 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-09-30.

At a glance

Inspections

8

Form 483s

5

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
20 Sep 2024 – 30 Sep 2024Human DrugsClean
20 Jun 2023 – 29 Jun 2023Medical Devices & Rad Health483View 483 →
2 May 2023 – 4 May 2023Human DrugsClean
25 Mar 2019 – 28 Mar 2019Human Drugs483View 483 →
11 Sep 2018 – 18 Sep 2018Human Drugs483On file
14 Aug 2017 – 18 Aug 2017Human Drugs483View 483 →
11 May 2016 – 16 May 2016Human DrugsWLOn file
5 Aug 2015 – 10 Aug 2015Human DrugsClean

Observations on record

Form 483 observations cited at this site, most recent first.

29 Jun 2023
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Frank J Marciniak

29 Jun 2023
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Frank J Marciniak

29 Jun 2023
21 CFR 820.30(a)

Design control - no procedures

Cited by Frank J Marciniak

29 Jun 2023
21 CFR 820.50(a)

Evaluation of suppliers, contractors, etc., requirements

Cited by Frank J Marciniak

29 Jun 2023
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Frank J Marciniak

Investigators

FDA investigators tied to this site in the record.

Michael Serrano3 insp.
Paul L Bellamy2 insp.
Frederick Razzaghi1 insp.
Frank J Marciniak1 insp.
Ashley J Burns1 insp.
Mihaela Jason1 insp.
James R Birkenstamm1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 314.80(c)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)(2)(ii)(A)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)(2)(ii)(B)Cited across public-safe Form 483 observations1x
21 CFR 314.80(d)Cited across public-safe Form 483 observations1x
21 CFR 314.80(j)Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.30(a)Cited across public-safe Form 483 observations1x
21 CFR 820.50(a)Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Navinta LLC's 5 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat