Atlas

FDA-Inspected Site

Aspire Pharmaceuticals, Inc.

11 FDA inspections are on record for Aspire Pharmaceuticals, Inc. in Somerset, United States.

483· Form 483 issued

Somerset, United States · Last updated July 9, 2026

Overview

  • 11 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-04-24.

At a glance

Inspections

11

Form 483s

5

EIRs

3

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
20 Apr 2026 – 24 Apr 2026Human Drugs483View 483 →
28 Jun 2023 – 14 Jul 2023Human Drugs483On file
29 Nov 2021 – 3 Feb 2022Foods & CosmeticsWLOn file
24 May 2017 – 1 Jun 2017Foods & CosmeticsClean
9 May 2014 – 19 May 2014Foods & Cosmetics483View 483 →
21 Jun 2010Not recorded483View 483 →
17 Nov 2006Not recordedClean
21 Mar 2006Not recordedClean
18 Mar 2005Not recordedClean
16 Apr 2003Not recordedClean
15 Feb 2002Not recordedClean

Observations on record

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

24 Apr 2026
21 CFR 211.182

Personnel dating/signing equipment log

Cited by Raihan A Chowdhury

24 Apr 2026
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Raihan A Chowdhury

19 May 2014
21 CFR 111.205(b)(1)

Master manufacturing record - specifications; quality

Cited by Raymond L Cheung

21 Jun 2010
21 CFR 111.103

Written procedures - quality control operations

Cited by Justine Tomasso, Doreen P Gubbay

21 Jun 2010
21 CFR 111.135

Quality control operations - product complaints; investigate

Cited by Justine Tomasso, Doreen P Gubbay

Investigators

FDA investigators tied to this site in the record.

Annet R Rajan2 insp.
Charlotte P Chang2 insp.
Raihan A Chowdhury1 insp.
Jessica M Monteiro1 insp.
Robin P Mathew1 insp.
Justin A Boyd1 insp.
Lata C Mathew1 insp.
Karen A Spencer1 insp.
Dhaval H Patel1 insp.
Raymond L Cheung1 insp.
Justine Tomasso1 insp.
Doreen P Gubbay1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 111.103Cited across public-safe Form 483 observations1x
21 CFR 111.135Cited across public-safe Form 483 observations1x
21 CFR 111.205(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.553Cited across public-safe Form 483 observations1x
21 CFR 111.560(b)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Aspire Pharmaceuticals, 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