Actavis Laboratories UT, Inc.
Form 483 issued August 20, 2021 · Salt Lake City, Utah
- Inspection
- Aug 16 – Aug 20, 2021
- Investigators
- Alan P. Kurtzberg· Dustin M. James
- Observations
- 1
- Pages
- 1
- FEI number
- 1000117147
In short: On August 20, 2021, FDA issued a Form 483 with 1 observation to Actavis Laboratories UT, Inc. in Salt Lake City, Utah (FEI 1000117147) after an inspection that ran Aug 16 – Aug 20, 2021. The investigators were Alan P. Kurtzberg and Dustin M. James. Most observations concern packaging & labeling; the most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria).
At a glance
1 of 1 observations on this 483 concern packaging & labeling.
Most cited: 21 CFR 211.122(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Labels and other labeling materials are not stored separately with suitable identification for each different drug…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmActavis Laboratories UT, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.122(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Actavis Laboratories UT, Inc.?
FDA listed 1 observation on this Form 483, mostly about packaging & labeling. The most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria). The opening words of each observation are shown on this page.
Who inspected Actavis Laboratories UT, Inc.?
Alan P. Kurtzberg and Dustin M. James are named on this Form 483, for the inspection of Aug 16 – Aug 20, 2021. Each investigator has a profile showing what they cite most.
When was Actavis Laboratories UT, Inc. inspected by FDA?
The inspection ran Aug 16 – Aug 20, 2021, and the Form 483 is dated August 20, 2021.
How do I get the full Form 483 for Actavis Laboratories UT, 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.