Catalent Micron Technologies, Inc
Form 483 issued April 20, 2016 · Malvern, Pennsylvania
- Inspection
- Apr 14 – Apr 20, 2016
- Investigator
- Anita R. Michael
- Observations
- 2
- Pages
- 1
- FEI number
- 3007992266
In short: On April 20, 2016, FDA issued a Form 483 with 2 observations to Catalent Micron Technologies, Inc in Malvern, Pennsylvania (FEI 3007992266) after an inspection that ran Apr 14 – Apr 20, 2016. The investigator was Anita R. Michael. Most observations concern production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.110 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
Specifically, for the following active pharmaceutical ingredients, process validation studies were not completed…
This inspection in context
Anita R. Michael
18 documents · 2006–2020
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmCatalent Micron Technologies, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Micron Technologies, Inc?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Catalent Micron Technologies, Inc?
Anita R. Michael is named on this Form 483, for the inspection of Apr 14 – Apr 20, 2016. Each investigator has a profile showing what they cite most.
When was Catalent Micron Technologies, Inc inspected by FDA?
The inspection ran Apr 14 – Apr 20, 2016, and the Form 483 is dated April 20, 2016.
How do I get the full Form 483 for Catalent Micron Technologies, 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.