Upsher Smith Laboratories, Inc.
Form 483 issued December 19, 2018 · Plymouth, Minnesota
- Inspection
- Nov 26 – Dec 19, 2018
- Investigators
- Courtney R. Ingalsbe· Ross J. Grigsby· Scott A. Golladay
- Observations
- 1
- Pages
- 5
- FEI number
- 2123200
In short: On December 19, 2018, FDA issued a Form 483 with 1 observation to Upsher Smith Laboratories, Inc. in Plymouth, Minnesota (FEI 2123200) after an inspection that ran Nov 26 – Dec 19, 2018. The investigators were Courtney R. Ingalsbe, Ross J. Grigsby and Scott A. Golladay. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Courtney R. Ingalsbe
4 documents · 2018–2020
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Minnesota.
The firmUpsher Smith Laboratories, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Upsher Smith Laboratories, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Upsher Smith Laboratories, Inc.?
Courtney R. Ingalsbe, Ross J. Grigsby and Scott A. Golladay are named on this Form 483, for the inspection of Nov 26 – Dec 19, 2018. Each investigator has a profile showing what they cite most.
When was Upsher Smith Laboratories, Inc. inspected by FDA?
The inspection ran Nov 26 – Dec 19, 2018, and the Form 483 is dated December 19, 2018.
How do I get the full Form 483 for Upsher Smith Laboratories, 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.