Jubilant HollisterStier LLC
Form 483 issued June 14, 2019 · Spokane, Washington
- Inspection
- Jun 14, 2019
- Investigators
- Bradley Dworak· Christine Harman
- Observations
- 4
- Pages
- 2
- FEI number
- 3010477
In short: On June 14, 2019, FDA issued a Form 483 with 4 observations to Jubilant HollisterStier LLC in Spokane, Washington (FEI 3010477) after an inspection that ran Jun 14, 2019. The investigators were Bradley Dworak and Christine Harman. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
4 of 4 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×) · 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
The shutdown procedure SOP 1608.9 "Quality Control of Jubilant HollisterStier Facility During and After Shutdown" is…
- 03
Batch production records do not include complete information relating to the production and…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Bradley Dworak
1 document · 2019
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Washington.
The firmJubilant HollisterStier LLC history
All 13 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jubilant HollisterStier LLC?
FDA listed 4 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Jubilant HollisterStier LLC?
Bradley Dworak and Christine Harman are named on this Form 483, for the inspection of Jun 14, 2019. Each investigator has a profile showing what they cite most.
When was Jubilant HollisterStier LLC inspected by FDA?
The inspection ran Jun 14, 2019, and the Form 483 is dated June 14, 2019.
How do I get the full Form 483 for Jubilant HollisterStier 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.