FDA-Inspected Site

Accra-Pac, Inc.

14 FDA inspections are on record for Accra-Pac, Inc. in Elkhart, United States.

483· Form 483 issued

Elkhart, United States · Last updated July 9, 2026

Overview

  • 14 FDA inspections are on record.
  • 7 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-03-05.

At a glance

Inspections

14

Form 483s

7

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
26 Feb 2026 – 5 Mar 2026Human Drugs483View 483 →
23 Aug 2022 – 2 Sep 2022Human DrugsWLOn file
2 Nov 2021 – 5 Nov 2021Medical Devices & Rad Health483View 483 →
27 Mar 2017 – 5 Apr 2017Human Drugs483View 483 →
3 Nov 2014 – 21 Nov 2014Human Drugs483View 483 →
12 Nov 2013 – 20 Nov 2013Human Drugs483View 483 →
27 Mar 2013Foods & CosmeticsClean
7 Jun 2012Not recorded483View 483 →
23 Aug 2011Not recordedClean
12 Mar 2010Not recordedClean
27 Apr 2009Not recordedClean
23 Jul 2007Not recordedClean

Observations on record

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

5 Mar 2026
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Amatul H Marium, WenNing Chan

5 Mar 2026
21 CFR 211.105(a)

Identification of containers, lines, equipment

Cited by Amatul H Marium, WenNing Chan

5 Mar 2026
21 CFR 211.67(c)

Cleaning/maintenance records not kept

Cited by Amatul H Marium, WenNing Chan

5 Mar 2026
21 CFR 211.68(b)

Computer control of master formula records

Cited by Amatul H Marium, WenNing Chan

5 Mar 2026
21 CFR 211.80(a)

Written Procedures Not Followed

Cited by Amatul H Marium, WenNing Chan

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 211.192Cited across public-safe Form 483 observations5x
21 CFR 211.22(d)Cited across public-safe Form 483 observations4x
21 CFR 211.160(a)Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.72(b)Cited across public-safe Form 483 observations2x
21 CFR 820.75(a)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.101(c)Cited across public-safe Form 483 observations1x
21 CFR 211.103Cited across public-safe Form 483 observations1x
21 CFR 211.105(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(c)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x
21 CFR 211.80(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(e)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Accra-Pac, Inc.'s 7 Form 483s

Source PDFs, 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