FDA-Inspected Site

Catalent Maryland, Inc.

3 FDA inspections are on record for Catalent Maryland, Inc. in Baltimore, United States.

483· Form 483 issued

Baltimore, United States · Last updated July 11, 2026

Overview

  • 3 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-04-09.

At a glance

Inspections

3

Form 483s

2

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
1 Apr 2025 – 9 Apr 2025Biologics483View 483 →
21 Feb 2023 – 24 Feb 2023BiologicsClean
28 Oct 2019 – 4 Nov 2019Biologics483On file

Observations on record

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

9 Apr 2025
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Lizaida Perez

9 Apr 2025
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Lizaida Perez

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 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Catalent Maryland, Inc.'s 2 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