Catalent Maryland, Inc.
Form 483 issued November 17, 2021 · Harmans, Maryland
- Investigator
- Bace Yan Wt Viheed
- Observations
- 7
- Pages
- 5
- FEI number
- 3015434301
In short: On November 17, 2021, FDA issued a Form 483 with 7 observations to Catalent Maryland, Inc. in Harmans, Maryland (FEI 3015434301). The investigator was Bace Yan Wt Viheed. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 5 of 7 observations.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm is not always manufacturing the (b) (4) within the validated ranges from the…
- 02
Procedures designed to accept a new product/manufacturing process did not include adequate steps to ensure proper…
- 03
There is insufficient quality oversight to fully investigate…
- 04
The procedure utilized for analyzing(b) (4) samples: Operation, Calibration, and Maintenance of the (b) (4) Text…
This inspection in context
Bace Yan Wt Viheed
1 document · 2021
Cites 211.42 (design and construction features) 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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Maryland, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Catalent Maryland, Inc.?
Bace Yan Wt Viheed is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Catalent Maryland, Inc. inspected by FDA?
This Form 483 is dated November 17, 2021.
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.