Catalent Maryland, Inc.
Form 483 issued March 10, 2023 · Harmans, Maryland
- Inspection
- Mar 6 – Mar 10, 2023
- Observations
- 2
- Pages
- 2
- FEI number
- 3015434301
In short: On March 10, 2023, FDA issued a Form 483 with 2 observations to Catalent Maryland, Inc. in Harmans, Maryland (FEI 3015434301) after an inspection that ran Mar 6 – Mar 10, 2023. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (2×) · 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
Your Quality Unit failed to ensure the integrity and effectiveness of…
- 02
The Quality Unit failed to address issues that have the potential to impact the…
This inspection in context
Questions about this 483
What did FDA find at Catalent Maryland, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
When was Catalent Maryland, Inc. inspected by FDA?
The inspection ran Mar 6 – Mar 10, 2023, and the Form 483 is dated March 10, 2023.
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.