FDA-Inspected Site

Solaris Pharma Corporation

4 FDA inspections are on record for Solaris Pharma Corporation in Somerset, United States.

483· Form 483 issued

Somerset, United States · Last updated July 11, 2026

Overview

  • 4 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-04-21.

At a glance

Inspections

4

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
21 Apr 2026Human Drugs483On file
16 Sep 2025 – 18 Sep 2025Human Drugs483View 483 →
6 Jan 2020 – 9 Jan 2020Human DrugsClean
28 Oct 2019 – 31 Oct 2019Human Drugs483View 483 →

Observations on record

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

18 Sep 2025
21 CFR 314.80(c)(2)

Late submission of annual safety reports

Cited by Brandy D Brown

31 Oct 2019
21 CFR 211.160(a)

Deviations from laboratory control requirements

Cited by Yvesna C Blaise, Loqman A Mohamed

31 Oct 2019
21 CFR 211.160(a)

Deviations from laboratory control requirements

Cited by Yvesna C Blaise, Loqman A Mohamed

31 Oct 2019
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Yvesna C Blaise, Loqman A Mohamed

31 Oct 2019
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Yvesna C Blaise, Loqman A Mohamed

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 211.160(a)Cited across public-safe Form 483 observations2x
21 CFR 211.67(a)Cited across public-safe Form 483 observations2x
21 CFR 211.68(b)Cited across public-safe Form 483 observations2x
21 CFR 314.80(c)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Solaris Pharma Corporation's 3 Form 483s

Source PDFs 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