Catalent Pharma Solutions LLC
Form 483 issued May 19, 2017 · Morrisville, North Carolina
- Inspection
- May 15 – May 19, 2017
- Investigator
- Tajah L. Blackburn
- Observations
- 2
- Pages
- 2
- FEI number
- 1000110912
In short: On May 19, 2017, FDA issued a Form 483 with 2 observations to Catalent Pharma Solutions LLC in Morrisville, North Carolina (FEI 1000110912) after an inspection that ran May 15 – May 19, 2017. The investigator was Tajah L. Blackburn. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.42(c)(8) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the…
This inspection in context
Tajah L. Blackburn
7 documents · 2015–2020
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in Maryland.
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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Pharma Solutions LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Catalent Pharma Solutions LLC?
Tajah L. Blackburn is named on this Form 483, for the inspection of May 15 – May 19, 2017. Each investigator has a profile showing what they cite most.
When was Catalent Pharma Solutions LLC inspected by FDA?
The inspection ran May 15 – May 19, 2017, and the Form 483 is dated May 19, 2017.
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.