Catalent Massachusetts, LLC
Form 483 issued April 7, 2026 · Chelsea, Massachusetts
- Inspection
- Apr 1 – Apr 7, 2026
- Investigators
- Armen H. Youssoufian· Ogechi C. Nna
- Observations
- 1
- Pages
- 3
- FEI number
- 3011696115
In short: On April 7, 2026, FDA issued a Form 483 with 1 observation to Catalent Massachusetts, LLC in Chelsea, Massachusetts (FEI 3011696115) after an inspection that ran Apr 1 – Apr 7, 2026. The investigators were Armen H. Youssoufian and Ogechi C. Nna. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Armen H. Youssoufian
9 documents · 2023–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmCatalent Massachusetts, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Massachusetts, LLC?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Catalent Massachusetts, LLC?
Armen H. Youssoufian and Ogechi C. Nna are named on this Form 483, for the inspection of Apr 1 – Apr 7, 2026. Each investigator has a profile showing what they cite most.
When was Catalent Massachusetts, LLC inspected by FDA?
The inspection ran Apr 1 – Apr 7, 2026, and the Form 483 is dated April 7, 2026.
How do I get the full Form 483 for Catalent Massachusetts, LLC?
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.