Catalent Maryland, Inc.
Form 483 issued November 4, 2019 · Baltimore, Maryland
- Inspection
- Oct 28 – Nov 4, 2019
- Observations
- 2
- Pages
- 2
- FEI number
- 3015558590
In short: On November 4, 2019, FDA issued a Form 483 with 2 observations to Catalent Maryland, Inc. in Baltimore, Maryland (FEI 3015558590) after an inspection that ran Oct 28 – Nov 4, 2019. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.192 (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 sterile are not…
- 02
Written records are not always made of…
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 production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
When was Catalent Maryland, Inc. inspected by FDA?
The inspection ran Oct 28 – Nov 4, 2019, and the Form 483 is dated November 4, 2019.
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.