Cephalon LLC
Form 483 issued August 30, 2024 · Salt Lake City, Utah
- Inspection
- Aug 26 – Aug 30, 2024
- Investigators
- Gunneet Kaur· Linda Thai
- Observations
- 2
- Pages
- 3
- FEI number
- 1000149927
In short: On August 30, 2024, FDA issued a Form 483 with 2 observations to Cephalon LLC in Salt Lake City, Utah (FEI 1000149927) after an inspection that ran Aug 26 – Aug 30, 2024. The investigators were Gunneet Kaur and Linda Thai. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.56 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 02
Written production and process control procedures are not documented at…
This inspection in context
Gunneet Kaur
9 documents · 2021–2024
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmCephalon LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.56
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cephalon LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
Who inspected Cephalon LLC?
Gunneet Kaur and Linda Thai are named on this Form 483, for the inspection of Aug 26 – Aug 30, 2024. Each investigator has a profile showing what they cite most.
When was Cephalon LLC inspected by FDA?
The inspection ran Aug 26 – Aug 30, 2024, and the Form 483 is dated August 30, 2024.
How do I get the full Form 483 for Cephalon 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.