Catalent Maryland, Inc.
Form 483 issued April 28, 2025 · Harmans, Maryland
- Inspection
- Apr 22 – Apr 28, 2025
- Investigators
- Alifiya H. Ghadiali· Ou Olivia Ma· Sarah Underwood
- Observations
- 6
- Pages
- 3
- FEI number
- 3015434301
In short: On April 28, 2025, FDA issued a Form 483 with 6 observations to Catalent Maryland, Inc. in Harmans, Maryland (FEI 3015434301) after an inspection that ran Apr 22 – Apr 28, 2025. The investigators were Alifiya H. Ghadiali, Ou Olivia Ma, Sarah Underwood and Sukyoung Sohn. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Identity testing is not conducted on the incoming drug substance used in the manufacture…
- 02
Written procedures for sterility release testing of drug product are deficient in that they do not…
- 03
Manufacturing equipment is not qualified…
- 04
Routine environmental monitoring program…
This inspection in context
Alifiya H. Ghadiali
2 documents · 2024–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Maryland.
The firmCatalent Maryland, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Maryland, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, materials and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Catalent Maryland, Inc.?
Alifiya H. Ghadiali, Ou Olivia Ma, Sarah Underwood and Sukyoung Sohn are named on this Form 483, for the inspection of Apr 22 – Apr 28, 2025. Each investigator has a profile showing what they cite most.
When was Catalent Maryland, Inc. inspected by FDA?
The inspection ran Apr 22 – Apr 28, 2025, and the Form 483 is dated April 28, 2025.
How do I get the full Form 483 for Catalent Maryland, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.