FDA-Inspected Site

Rohtstein Corp.

13 FDA inspections are on record for Rohtstein Corp. in Woburn, United States.

Clean· No action indicated

Woburn, United States · Last updated August 15, 2026

Overview

  • 13 FDA inspections are on record.
  • 8 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-06-11.

At a glance

Inspections

13

Form 483s

8

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
26 May 2026 – 11 Jun 2026Foods & CosmeticsClean
6 May 2025 – 19 May 2025Foods & Cosmetics483View 483 →
23 Apr 2024 – 16 May 2024Foods & Cosmetics483View 483 →
23 Sep 2021 – 29 Sep 2021Foods & Cosmetics483View 483 →
12 Jul 2017 – 13 Jul 2017Foods & Cosmetics483View 483 →
16 Sep 2014Foods & Cosmetics483On file
22 Dec 2011Not recorded483View 483 →
8 Jul 2010Not recorded483View 483 →
29 Sep 2009Not recordedClean
17 Sep 2008Not recorded483On file
4 May 2006Not recordedClean
11 Apr 2005Not recordedClean

Observations on record

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

19 May 2025
21 CFR 108.25(c)(2)

Process filing

Cited by Erich P Garger

19 May 2025
21 CFR 108.25(c)(3)(i)

Process adherence

Cited by Erich P Garger

19 May 2025
21 CFR 114.80(a)

Quality control procedures

Cited by Erich P Garger

16 May 2024
21 CFR 108.25(c)(3)(i)

Process adherence

Cited by Thomas Siebertz

16 May 2024
21 CFR 114.80(a)

Quality control procedures

Cited by Thomas Siebertz

Investigators

FDA investigators tied to this site in the record.

State Agency1 insp.
Louis Christy1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 110.40(c)Cited across public-safe Form 483 observations3x
21 CFR 110.40(f)Cited across public-safe Form 483 observations3x
21 CFR 114.100(a)Cited across public-safe Form 483 observations3x
21 CFR 108.25(c)(2)Cited across public-safe Form 483 observations2x
21 CFR 108.25(c)(3)(i)Cited across public-safe Form 483 observations2x
21 CFR 110.35(d)Cited across public-safe Form 483 observations2x
21 CFR 114.80(a)Cited across public-safe Form 483 observations2x
21 CFR 108.25(e)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 114.100(c)Cited across public-safe Form 483 observations1x
21 CFR 114.80(b)Cited across public-safe Form 483 observations1x
21 CFR 117.40Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Rohtstein Corp.'s 8 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