Atlas

FDA-Inspected Site

American Specialty Manufacturing Company, Inc.

10 FDA inspections are on record for American Specialty Manufacturing Company, Inc. in Rochester, United States.

Clean· No action indicated

Rochester, United States · Last updated July 10, 2026

Overview

  • 10 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-06-04.

At a glance

Inspections

10

Form 483s

3

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
4 Jun 2026Foods & CosmeticsClean
10 Jul 2019Foods & CosmeticsClean
31 Oct 2016Foods & CosmeticsClean
26 Feb 2014 – 28 Feb 2014Foods & CosmeticsClean
2 Jun 2011Not recorded483View 483 →
17 Feb 2010Not recordedClean
12 Mar 2009Not recorded483On file
20 Mar 2008Not recorded483On file
18 Mar 2004Not recordedClean
7 Dec 2001Not recordedClean

Observations on record

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

2 Jun 2011
21 CFR 108.25(c)(1)

Registration

Cited by Marc S Neubauer

2 Jun 2011
21 CFR 108.25(c)(2)

Process filing

Cited by Marc S Neubauer

2 Jun 2011
21 CFR 110.35(a)

Buildings/sanitary

Cited by Marc S Neubauer

2 Jun 2011
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Marc S Neubauer

2 Jun 2011
21 CFR 110.35(d)

Failure to clean - general

Cited by Marc S Neubauer

Investigators

FDA investigators tied to this site in the record.

State Agency3 insp.
John P Shelton1 insp.
Elizabeth H Davis1 insp.
Mary Alice B Garlipp1 insp.
Hilary K Wagner1 insp.
Marc S Neubauer1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 108.25(c)(1)Cited across public-safe Form 483 observations1x
21 CFR 108.25(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 114.100(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind American Specialty Manufacturing Company, Inc.'s 3 Form 483s

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