Upsher-Smith Laboratories, LLC
Form 483 issued November 7, 2019 · Denver, Colorado
- Inspection
- Nov 4 – Nov 7, 2019
- Investigator
- Erika V. Butler
- Observations
- 2
- Pages
- 5
- FEI number
- 1719991
In short: On November 7, 2019, FDA issued a Form 483 with 2 observations to Upsher-Smith Laboratories, LLC in Denver, Colorado (FEI 1719991) after an inspection that ran Nov 4 – Nov 7, 2019. The investigator was Erika V. Butler. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
This inspection in context
Erika V. Butler
23 documents · 2007–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmUpsher-Smith Laboratories, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Upsher-Smith Laboratories, LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Upsher-Smith Laboratories, LLC?
Erika V. Butler is named on this Form 483, for the inspection of Nov 4 – Nov 7, 2019. Each investigator has a profile showing what they cite most.
When was Upsher-Smith Laboratories, LLC inspected by FDA?
The inspection ran Nov 4 – Nov 7, 2019, and the Form 483 is dated November 7, 2019.
How do I get the full Form 483 for Upsher-Smith Laboratories, 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.