FDA-Inspected Site

Advanced Pharmaceutical Technology, Inc.

4 FDA inspections are on record for Advanced Pharmaceutical Technology, Inc. in Elmsford, United States.

483· Form 483 issued

Elmsford, United States · Last updated July 10, 2026

Overview

  • 4 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-08-01.

At a glance

Inspections

4

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
10 Jul 2024 – 1 Aug 2024Human DrugsWLView 483 →
5 Aug 2021 – 23 Aug 2021Human Drugs483View 483 →
10 Sep 2019 – 27 Sep 2019Human Drugs483View 483 →
14 Jul 2014Medical Devices & Rad HealthClean

Observations on record

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

1 Aug 2024
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Gam S Zamil

1 Aug 2024
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Gam S Zamil

1 Aug 2024
21 CFR 211.142(b)

Storage under appropriate conditions

Cited by Gam S Zamil

1 Aug 2024
21 CFR 211.165(a)

Testing and release for distribution

Cited by Gam S Zamil

1 Aug 2024
21 CFR 211.166(a)

Lack of written stability program

Cited by Gam S Zamil

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 211.100(a)Cited across public-safe Form 483 observations4x
21 CFR 211.165(a)Cited across public-safe Form 483 observations3x
21 CFR 211.166(a)Cited across public-safe Form 483 observations3x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations3x
21 CFR 211.188(b)Cited across public-safe Form 483 observations2x
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.142(b)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(3)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Advanced Pharmaceutical Technology, Inc.'s 3 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