Atlas

FDA-Inspected Site

Pharmaceutics International, Inc.

14 FDA inspections are on record for Pharmaceutics International, Inc. in Cockeysville, United States.

483· Form 483 issued

Cockeysville, United States · Last updated July 9, 2026

Overview

  • 14 FDA inspections are on record.
  • 13 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-03-06.

At a glance

Inspections

14

Form 483s

13

EIRs

4

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
23 Feb 2026 – 6 Mar 2026Human Drugs483View 483 →
10 Jun 2024 – 12 Jun 2024Medical Devices & Rad HealthClean
10 May 2022 – 14 Nov 2022Human Drugs483On file
26 Jul 2021 – 29 Sep 2021Human Drugs483On file
19 Oct 2020 – 30 Oct 2020Human Drugs483View 483 →
6 Jul 2020 – 10 Jul 2020Human Drugs483View 483 →
24 Oct 2018 – 9 Nov 2018Human Drugs483View 483 →
16 Oct 2017 – 27 Oct 2017Human Drugs483View 483 →
21 Mar 2016 – 4 Apr 2016Human Drugs483View 483 →
11 May 2015 – 29 May 2015Human Drugs483View 483 →
7 Jul 2014 – 17 Jul 2014Human Drugs483View 483 →
27 Aug 2013 – 13 Sep 2013Human Drugs483View 483 →

Observations on record

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

6 Mar 2026
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Daniel T Lee, Tanya R Syffrard, Pushpa S Jayasekara, Michelle Lin

6 Mar 2026
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Daniel T Lee, Tanya R Syffrard, Pushpa S Jayasekara, Michelle Lin

6 Mar 2026
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Daniel T Lee, Tanya R Syffrard, Pushpa S Jayasekara, Michelle Lin

6 Mar 2026
21 CFR 211.160(a)

Deviations from laboratory control requirements

Cited by Daniel T Lee, Tanya R Syffrard, Pushpa S Jayasekara, Michelle Lin

6 Mar 2026
21 CFR 211.188

Prepared for each batch, include complete information

Cited by Daniel T Lee, Tanya R Syffrard, Pushpa S Jayasekara, Michelle Lin

Investigators

FDA investigators tied to this site in the record.

Toyin B Oladimeji3 insp.
Robert J Martin2 insp.
Simone E Pitts2 insp.
Jonathan W Chapman2 insp.
Brooke K Higgins2 insp.
Daniel T Lee1 insp.
Tanya R Syffrard1 insp.
Pushpa S Jayasekara1 insp.
Michelle Lin1 insp.
Christina D Mello1 insp.
Bijoy Panicker1 insp.
Christina K Theodorou1 insp.
Erik W Koester1 insp.
Jonah S Ufferfilge1 insp.
Vivin George1 insp.
Rachael O Oyewole1 insp.
Kristina L Conroy1 insp.
Marcellinus D Dordunoo1 insp.
Viviana Matta1 insp.
Shirshendu K Deb1 insp.
Kathleen M Jordan1 insp.
Yvins Dezan1 insp.
Junho Pak1 insp.
Edmund F Mrak1 insp.
David A Oluwo1 insp.
James M Simpson1 insp.
Michael Shanks1 insp.
Alice S Tsao1 insp.
Alison N Stieg1 insp.
Marcus A Ray1 insp.
Thomas E Friel1 insp.
Deyaa Shaheen1 insp.
Eric L Dong1 insp.
Samina S Khan1 insp.
Nadeem I Chaudhry1 insp.
Rebecca Rodriguez1 insp.
Marc S Neubauer1 insp.
Alberto A Viciedo1 insp.
Rachel C Harrington1 insp.
Nebil A Oumer1 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 observations22x
21 CFR 211.67(a)Cited across public-safe Form 483 observations15x
21 CFR 211.192Cited across public-safe Form 483 observations12x
21 CFR 211.100(a)Cited across public-safe Form 483 observations10x
21 CFR 211.63Cited across public-safe Form 483 observations10x
21 CFR 211.22(d)Cited across public-safe Form 483 observations9x
21 CFR 820.50Cited across public-safe Form 483 observations6x
21 CFR 211.160(a)Cited across public-safe Form 483 observations5x
21 CFR 211.160(b)Cited across public-safe Form 483 observations5x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations5x
21 CFR 211.165(b)Cited across public-safe Form 483 observations5x
21 CFR 211.25(a)Cited across public-safe Form 483 observations5x
21 CFR 211.67(b)Cited across public-safe Form 483 observations5x
21 CFR 820.70(a)Cited across public-safe Form 483 observations5x
21 CFR 820.75(a)Cited across public-safe Form 483 observations5x
21 CFR 211.100(b)Cited across public-safe Form 483 observations4x
21 CFR 211.110(a)Cited across public-safe Form 483 observations4x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations4x
21 CFR 211.46(c)Cited across public-safe Form 483 observations4x
21 CFR 211.68(b)Cited across public-safe Form 483 observations4x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations3x
21 CFR 211.28(b)Cited across public-safe Form 483 observations3x
21 CFR 211.80(a)Cited across public-safe Form 483 observations3x
21 CFR 211.89Cited across public-safe Form 483 observations3x
21 CFR 211.188Cited across public-safe Form 483 observations2x
21 CFR 211.42(a)Cited across public-safe Form 483 observations2x
21 CFR 211.46(b)Cited across public-safe Form 483 observations2x
21 CFR 211.84(d)(3)Cited across public-safe Form 483 observations2x
21 CFR 211.110(c)Cited across public-safe Form 483 observations1x
21 CFR 211.111Cited across public-safe Form 483 observations1x
21 CFR 211.134(c)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(i)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iii)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations1x
21 CFR 211.56(a)Cited across public-safe Form 483 observations1x
21 CFR 820.20(b)Cited across public-safe Form 483 observations1x
21 CFR 820.20(d)Cited across public-safe Form 483 observations1x
21 CFR 820.30(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Pharmaceutics International, Inc.'s 13 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