FDA Form 483 Catalent Baltimore April 2025
Form 483 issued April 9, 2025 · Ba l t i more, Maryland
- Inspection
- Apr 1 – Apr 9, 2025
- Investigator
- Li Zaida Perez
- Observations
- 2
- Pages
- 3
In short: On April 9, 2025, FDA issued a Form 483 with 2 observations to FDA Form 483 Catalent Baltimore April 2025 in Ba l t i more, Maryland after an inspection that ran Apr 1 – Apr 9, 2025. The investigator was Li Zaida Perez. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.58 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Buildings used in the manufacturing of a drug product are not maintained in a…
This inspection in context
Li Zaida Perez
1 document · 2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Maryland.
The firmFDA Form 483 Catalent Baltimore April 2025 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FDA Form 483 Catalent Baltimore April 2025?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected FDA Form 483 Catalent Baltimore April 2025?
Li Zaida Perez is named on this Form 483, for the inspection of Apr 1 – Apr 9, 2025. Each investigator has a profile showing what they cite most.
When was FDA Form 483 Catalent Baltimore April 2025 inspected by FDA?
The inspection ran Apr 1 – Apr 9, 2025, and the Form 483 is dated April 9, 2025.
How do I get the full Form 483 for FDA Form 483 Catalent Baltimore April 2025?
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.