FDA-Inspected Site

Nova Pneuma, Inc.

10 FDA inspections are on record for Nova Pneuma, Inc. in Fremont, United States.

Clean· No action indicated

Fremont, United States · Last updated July 10, 2026

Overview

  • 10 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-12-19.

At a glance

Inspections

10

Form 483s

5

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
15 Dec 2025 – 19 Dec 2025Human DrugsClean
31 Jul 2025 – 1 Aug 2025Human DrugsClean
21 Dec 2023 – 22 Dec 2023Human DrugsClean
23 Sep 2019 – 26 Sep 2019Human DrugsClean
18 May 2015 – 21 May 2015Medical Devices & Rad Health483On file
12 Feb 2014 – 13 Feb 2014Human DrugsClean
8 Jan 2014 – 22 Jan 2014Human Drugs483View 483 →
8 Nov 2012Not recorded483View 483 →
12 Dec 2011Not recorded483On file
20 Aug 2010Not recorded483View 483 →

Observations on record

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

22 Jan 2014
21 CFR 211.68(b)

input/output verification

Cited by Ashar P Parikh

22 Jan 2014
21 CFR 211.192

No written record of investigation

Cited by Ashar P Parikh

8 Nov 2012
21 CFR 211.188

Prepared for each batch, include complete information

Cited by Mark E Chan, Caryn M Mcnab

8 Nov 2012
21 CFR 211.188(b)(7)

Actual yield, % of theoretical yield

Cited by Mark E Chan, Caryn M Mcnab

20 Aug 2010
21 CFR 211.22(a)

Authority lacking to review records, investigate errors

Cited by Mark E Chan, Peter E Baker

Investigators

FDA investigators tied to this site in the record.

Anney Lin1 insp.
Daniel J Roberts1 insp.
David Eng1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.142Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x
21 CFR 820.100(b)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 Nova Pneuma, Inc.'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