Catalent Pharma Solutions LLC
Form 483 issued March 20, 2015 · Morrisville, North Carolina
- Inspection
- Mar 16 – Mar 20, 2015
- Investigators
- Charanjeet S. Jassal· Seneca Toms
- Observations
- 6
- Pages
- 4
- FEI number
- 1000110912
In short: On March 20, 2015, FDA issued a Form 483 with 6 observations to Catalent Pharma Solutions LLC in Morrisville, North Carolina (FEI 1000110912) after an inspection that ran Mar 16 – Mar 20, 2015. The investigators were Charanjeet S. Jassal and Seneca Toms. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Quality system and laboratory controls account for 4 of 6 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Charanjeet S. Jassal
5 documents · 2015–2016
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Pharma Solutions LLC?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and materials. 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?
Charanjeet S. Jassal and Seneca Toms are named on this Form 483, for the inspection of Mar 16 – Mar 20, 2015. Each investigator has a profile showing what they cite most.
When was Catalent Pharma Solutions LLC inspected by FDA?
The inspection ran Mar 16 – Mar 20, 2015, and the Form 483 is dated March 20, 2015.
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.