Atlas

FDA-Inspected Site

Dr. Rath International, Inc.

3 FDA inspections are on record for Dr. Rath International, Inc. in San Jose, United States.

483· Form 483 issued

San Jose, United States · Last updated July 9, 2026

Overview

  • 3 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-03-26.

At a glance

Inspections

3

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
23 Mar 2026 – 26 Mar 2026Foods & Cosmetics483View 483 →
14 Aug 2017 – 16 Aug 2017Foods & Cosmetics483View 483 →
29 Apr 2013 – 21 May 2013Foods & Cosmetics483View 483 →

Observations on record

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

26 Mar 2026
21 CFR 111.103

Written procedures - establish; quality control operations

Cited by Kimiko G Casuga

26 Mar 2026
21 CFR 111.12

Personnel - qualifications

Cited by Kimiko G Casuga

26 Mar 2026
21 CFR 111.180(b)(3)

Documentation - requirements

Cited by Kimiko G Casuga

26 Mar 2026
21 CFR 111.410(b)

Label, packaging - discrepancies

Cited by Kimiko G Casuga

26 Mar 2026
21 CFR 111.415(f)

Batch, lot, control number

Cited by Kimiko G Casuga

Investigators

FDA investigators tied to this site in the record.

Kimiko G Casuga1 insp.
Helen J Hamaoka1 insp.
Jeanmaire Hryshko1 insp.
Ronald P Boyce1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 111.553Cited across public-safe Form 483 observations4x
21 CFR 111.103Cited across public-safe Form 483 observations3x
21 CFR 111.55Cited across public-safe Form 483 observations3x
21 CFR 111.23(b)Cited across public-safe Form 483 observations2x
21 CFR 111.535(b)(2)Cited across public-safe Form 483 observations2x
21 CFR 111.12Cited across public-safe Form 483 observations1x
21 CFR 111.127Cited across public-safe Form 483 observations1x
21 CFR 111.180(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 111.20(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.205(a)Cited across public-safe Form 483 observations1x
21 CFR 111.255(a)Cited across public-safe Form 483 observations1x
21 CFR 111.410(b)Cited across public-safe Form 483 observations1x
21 CFR 111.415(f)Cited across public-safe Form 483 observations1x
21 CFR 111.453Cited across public-safe Form 483 observations1x
21 CFR 111.535(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.560(c)Cited across public-safe Form 483 observations1x
21 CFR 111.65Cited across public-safe Form 483 observations1x
21 CFR 111.73Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Dr. Rath International, 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