Atlas

FDA-Inspected Site

Alk-abello, Inc.

13 FDA inspections are on record for Alk-abello, Inc. in Port Washington, United States.

483· Form 483 issued

Port Washington, United States · Last updated July 10, 2026

Overview

  • 13 FDA inspections are on record.
  • 7 inspections produced a Form 483.
  • The most recent recorded inspection date is 2023-10-17.

At a glance

Inspections

13

Form 483s

7

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
11 Oct 2023 – 17 Oct 2023Biologics483View 483 →
2 Mar 2023 – 9 Mar 2023Biologics483On file
24 Oct 2018 – 30 Oct 2018Biologics483View 483 →
14 Dec 2016 – 21 Dec 2016Biologics483On file
11 Feb 2014 – 25 Feb 2014BiologicsClean
21 Mar 2012Not recorded483On file
19 Nov 2009Not recorded483On file
13 Feb 2008Not recorded483On file
3 Aug 2006Not recordedClean
13 Apr 2004Not recordedClean
18 Jul 2002Not recordedClean
2 Nov 2000Not recordedClean

Observations on record

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

17 Oct 2023
21 CFR 211.192

Written record of investigation incomplete

Cited by Shafiq Ahadi, Helen B Ricalde, Christian Lynch

30 Oct 2018
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Susan M Jackson

30 Oct 2018
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Susan M Jackson

Investigators

FDA investigators tied to this site in the record.

Christian Lynch2 insp.
Burnell M Henry2 insp.
Susan M Jackson2 insp.
Shafiq Ahadi1 insp.
Helen B Ricalde1 insp.
Thomas R Withers1 insp.
Cynthia Jim1 insp.
Jacqueline M Diaz Albert1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Alk-abello, 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