Catalent Pharma Solutions LLC
Form 483 issued December 15, 2022 · Morrisville, North Carolina
- Inspection
- Dec 5 – Dec 15, 2022
- Investigator
- Philip F. Istafanos
- Observations
- 4
- Pages
- 6
- FEI number
- 1000110912
In short: On December 15, 2022, FDA issued a Form 483 with 4 observations to Catalent Pharma Solutions LLC in Morrisville, North Carolina (FEI 1000110912) after an inspection that ran Dec 5 – Dec 15, 2022. The investigator was Philip F. Istafanos. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
4 of 4 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Test procedures relative to appropriate laboratory testing for…
- 02
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
- 03
The accuracy of test methods…
- 04
Established test procedures and laboratory control…
This inspection in context
Philip F. Istafanos
13 documents · 2014–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Canada.
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 211.167(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Pharma Solutions LLC?
FDA listed 4 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Catalent Pharma Solutions LLC?
Philip F. Istafanos is named on this Form 483, for the inspection of Dec 5 – Dec 15, 2022. Each investigator has a profile showing what they cite most.
When was Catalent Pharma Solutions LLC inspected by FDA?
The inspection ran Dec 5 – Dec 15, 2022, and the Form 483 is dated December 15, 2022.
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.