Jubilant HollisterStier LLC
Form 483 issued June 6, 2024 · Spokane, Washington
- Inspection
- May 28 – Jun 6, 2024
- Investigators
- Christopher R. Czajka· Michael T. Cyrus· Roger F. Zabinski
- Observations
- 3
- Pages
- 5
- FEI number
- 3010477
In short: On June 6, 2024, FDA issued a Form 483 with 3 observations to Jubilant HollisterStier LLC in Spokane, Washington (FEI 3010477) after an inspection that ran May 28 – Jun 6, 2024. The investigators were Christopher R. Czajka, Michael T. Cyrus, Roger F. Zabinski and Walden H. Lee. Most observations concern quality system and production.
At a glance
Quality system and production account for 2 of 3 observations.
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…
- 02
Written production and process control procedures are not followed in the execution of production…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jubilant HollisterStier LLC?
FDA listed 3 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Jubilant HollisterStier LLC?
Christopher R. Czajka, Michael T. Cyrus, Roger F. Zabinski and Walden H. Lee are named on this Form 483, for the inspection of May 28 – Jun 6, 2024. Each investigator has a profile showing what they cite most.
When was Jubilant HollisterStier LLC inspected by FDA?
The inspection ran May 28 – Jun 6, 2024, and the Form 483 is dated June 6, 2024.
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.