CATALENT GREENVILLE, INC.
Form 483 issued July 12, 2019 · Greenville, North Carolina
- Investigator
- Claire M. Minden
- Observations
- 2
- Pages
- 3
- FEI number
- 3000209735
In short: On July 12, 2019, FDA issued a Form 483 with 2 observations to CATALENT GREENVILLE, INC. in Greenville, North Carolina (FEI 3000209735). The investigator was Claire M. Minden. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.160(b) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Claire M. Minden
26 documents · 2013–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Louisiana.
The firmCATALENT GREENVILLE, INC. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CATALENT GREENVILLE, INC.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. 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 GREENVILLE, INC.?
Claire M. Minden is named on this Form 483. Each investigator has a profile showing what they cite most.
When was CATALENT GREENVILLE, INC. inspected by FDA?
This Form 483 is dated July 12, 2019.
How do I get the full Form 483 for CATALENT GREENVILLE, INC.?
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.