FDA-Inspected Site

Cerovene Inc.

12 FDA inspections are on record for Cerovene Inc. in Valley Cottage, United States.

483· Form 483 issued

Valley Cottage, United States · Last updated July 9, 2026

Overview

  • 12 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-03-23.

At a glance

Inspections

12

Form 483s

5

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
16 Mar 2026 – 23 Mar 2026Human Drugs483On file
21 Apr 2025 – 28 Apr 2025Human Drugs483View 483 →
24 Jul 2023 – 1 Aug 2023Human DrugsClean
30 Oct 2018 – 5 Nov 2018Human DrugsClean
6 Nov 2017Human DrugsClean
26 Jan 2017 – 8 Feb 2017Human Drugs483On file
21 Apr 2015 – 4 May 2015Human Drugs483On file
3 Oct 2013 – 15 Oct 2013Human Drugs483View 483 →
20 Sep 2012Not recordedClean
8 Mar 2011Not recordedClean
4 Jan 2010Not recordedClean
8 Feb 2008Not recordedClean

Observations on record

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

28 Apr 2025
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Jenny Sung, JoshRenzo N Ramilo

28 Apr 2025
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Jenny Sung, JoshRenzo N Ramilo

28 Apr 2025
21 CFR 211.68(b)

Computer control of master formula records

Cited by Jenny Sung, JoshRenzo N Ramilo

15 Oct 2013
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Sony Mathews

15 Oct 2013
21 CFR 211.110(b)

In-process materials specifications testing

Cited by Sony Mathews

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.110(b)Cited across public-safe Form 483 observations1x
21 CFR 211.110(c)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Cerovene 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