Catalent Pharma Solutions LLC
Form 483 issued September 28, 2020 · Morrisville, North Carolina
- Inspection
- Sep 21 – Sep 28, 2020
- Investigators
- Gamal A. Norton· Seneca Toms
- Observations
- 5
- Pages
- 5
- FEI number
- 1000110912
In short: On September 28, 2020, FDA issued a Form 483 with 5 observations to Catalent Pharma Solutions LLC in Morrisville, North Carolina (FEI 1000110912) after an inspection that ran Sep 21 – Sep 28, 2020. The investigators were Gamal A. Norton and Seneca Toms. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
5 of 5 observations on this 483 concern design controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design validation have…
- 02
Procedures for design verification have…
- 03
Procedures for design input…
- 04
Design plans that describe or reference the design and development activities and define responsibility for implementation…
This inspection in context
Gamal A. Norton
16 documents · 2003–2025
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in North Carolina.
The firmCatalent Pharma Solutions LLC history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Pharma Solutions LLC?
FDA listed 5 observations on this Form 483, mostly about design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Catalent Pharma Solutions LLC?
Gamal A. Norton and Seneca Toms are named on this Form 483, for the inspection of Sep 21 – Sep 28, 2020. Each investigator has a profile showing what they cite most.
When was Catalent Pharma Solutions LLC inspected by FDA?
The inspection ran Sep 21 – Sep 28, 2020, and the Form 483 is dated September 28, 2020.
How do I get the full Form 483 for Catalent Pharma Solutions 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.