FDA-Inspected Site

Associates of Cape Cod, Inc.

18 FDA inspections are on record for Associates of Cape Cod, Inc. in East Falmouth, United States.

Clean· No action indicated

East Falmouth, United States · Last updated July 10, 2026

Overview

  • 18 FDA inspections are on record.
  • 8 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-07-16.

At a glance

Inspections

18

Form 483s

8

EIRs

3

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
14 Jul 2025 – 16 Jul 2025Human DrugsClean
27 Mar 2025 – 3 Apr 2025Biologics483View 483 →
19 Oct 2021 – 21 Oct 2021Medical Devices & Rad Health483View 483 →
19 Nov 2019 – 26 Nov 2019Human Drugs483View 483 →
31 Oct 2018 – 8 Nov 2018Biologics483On file
3 Oct 2016 – 11 Oct 2016Human DrugsClean
27 Apr 2016 – 3 May 2016Biologics483On file
13 May 2014 – 16 May 2014Human Drugs483On file
18 Jun 2013 – 25 Jun 2013Biologics483On file
9 Aug 2011Not recordedClean
26 Jul 2010Not recordedClean
21 Sep 2009Not recordedClean

Observations on record

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

3 Apr 2025
21 CFR 211.180(e)

Records reviewed annually

Cited by Burnell M Henry

21 Oct 2021
21 CFR 820.100(b)

Documentation

Cited by Nabil Nakhoul

21 Oct 2021
21 CFR 820.100(b)

Documentation

Cited by Nabil Nakhoul

26 Nov 2019
21 CFR 211.194(a)(4)

Complete Test Data

Cited by Erik W Koester

26 Nov 2019
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Erik W Koester

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 820.100(b)Cited across public-safe Form 483 observations2x
21 CFR 211.180(e)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Associates of Cape Cod, Inc.'s 8 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