FDA-Inspected Site

Majestic Drug Co Inc

3 FDA inspections are on record for Majestic Drug Co Inc in South Fallsburg, United States.

483· Form 483 issued

South Fallsburg, United States · Last updated July 10, 2026

Overview

  • 3 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2016-12-19.

At a glance

Inspections

3

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
8 Dec 2016 – 19 Dec 2016Medical Devices & Rad Health483View 483 →
29 Nov 2012Not recordedClean
26 Oct 2010Not recordedClean

Observations on record

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

19 Dec 2016
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Jacqueline S Warner

19 Dec 2016
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Jacqueline S Warner

19 Dec 2016
21 CFR 820.100(b)

Documentation

Cited by Jacqueline S Warner

19 Dec 2016
21 CFR 820.100(b)

Documentation

Cited by Jacqueline S Warner

19 Dec 2016
21 CFR 820.20(e)

Quality System Procedures

Cited by Jacqueline S Warner

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 803.17Cited across public-safe Form 483 observations2x
21 CFR 820.100(b)Cited across public-safe Form 483 observations2x
21 CFR 820.20(e)Cited across public-safe Form 483 observations2x
21 CFR 820.30(a)Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind Majestic Drug Co Inc's 1 Form 483

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