FDA-Inspected Site

Identipak Inc

5 FDA inspections are on record for Identipak Inc in Mcallen, United States.

483· Form 483 issued

Mcallen, United States · Last updated July 10, 2026

Overview

  • 5 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-12-18.

At a glance

Inspections

5

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
15 Dec 2025 – 18 Dec 2025Human Drugs483View 483 →
3 Jun 2025 – 5 Jun 2025Medical Devices & Rad Health483On file
7 Jun 2016 – 8 Jun 2016Human DrugsClean
22 Jun 2011Not recordedClean
21 May 2009Not recordedClean

Observations on record

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

18 Dec 2025
21 CFR 211.180(e)(1)

Review of representative number of batches

Cited by Rodney L Tinzie

18 Dec 2025
21 CFR 211.67(b)(3)

Cleaning SOPs/instructions

Cited by Rodney L Tinzie

18 Dec 2025
21 CFR 211.67(c)

Cleaning/maintenance records not kept

Cited by Rodney L Tinzie

Investigators

FDA investigators tied to this site in the record.

State Agency1 insp.
Patricia M Jacobs1 insp.
Cntrctmntr Martinez1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.67(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Identipak Inc's 2 Form 483s

Source PDFs 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