Catalent Pharma Solutions LLC
FDA inspection history in Morrisville, North Carolina, 2015 to 2024
- 6
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2017: one Form 483; 2019: one Form 483; 2020: one Form 483; 2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–24Six Form 483s, at Morrisville, North Carolina.
- 2015The longest 483 on file: 6 observations over 4 pages at Morrisville, North Carolina.
Cited most
Across all Catalent Pharma Solutions observations on file
- 21 CFR 820.30(b)Design controls5
- 21 CFR 211.160General requirements4
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.67Equipment cleaning and maintenance2
The complete Catalent Pharma Solutions file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Morrisville, North Carolina
Six Form 483s · 2015 to 2024 · 22 observations
Latest: Form 483, May 24, 2024 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-05-24 | 483 Form 483 | Morrisville, North Carolina | 1 | $99 |
| 2022-12-15 | 483 Form 483 | Morrisville, North Carolina | 4 | $99 |
| 2020-09-28 | 483 Form 483 | Morrisville, North Carolina | 5 | $99 |
| 2019-03-04 | 483 Form 483 | Morrisville, North Carolina | 4 | $99 |
| 2017-05-19 | 483 Form 483 | Morrisville, North Carolina | 2 | $99 |
| 2015-03-20 | 483 Form 483 | Morrisville, North Carolina | 6 | $99 |
Investigators on these documents
Seneca Toms (2)Gamal A. Norton (1)Philip F. Istafanos (1)Richard L. Bartlett (1)Sonya M. Edmonds (1)Tajah L. Blackburn (1)Charanjeet S. Jassal (1)Travis S. Bradley (1)
FEI number 1000110912 · most recent document May 24, 2024
About Catalent Pharma Solutions LLC
How many FDA Form 483s has Catalent Pharma Solutions LLC received?
FDA Intel has 6 Form 483s on file for Catalent Pharma Solutions LLC; the most recent is dated May 24, 2024.
When was Catalent Pharma Solutions LLC last inspected by FDA?
The most recent FDA inspection document on file for Catalent Pharma Solutions LLC is a Form 483 dated May 24, 2024, for the site in Morrisville, North Carolina.
What did FDA cite at Catalent Pharma Solutions LLC?
The regulations cited most in the observations on file for Catalent Pharma Solutions LLC are 21 CFR 820.30(b) (Design controls), 5 times; 21 CFR 211.160 (General requirements), 4 times; 21 CFR 211.192 (Production record review), 2 times.