Jubilant HollisterStier LLC
Form 483 issued June 17, 2026 · Spokane, Washington
- Inspection
- Jun 8 – Jun 17, 2026
- Investigators
- Anney Lin· Bryan L. McGuckin· Cecilia H. Kieu
- Observations
- 2
- Pages
- 12
- FEI number
- 3010477
In short: On June 17, 2026, FDA issued a Form 483 with 2 observations to Jubilant HollisterStier LLC in Spokane, Washington (FEI 3010477) after an inspection that ran Jun 8 – Jun 17, 2026. The investigators were Anney Lin, Bryan L. McGuckin, Cecilia H. Kieu, Homero W. Aguilar, Katherine E. Jacobitz, Katie L. Penno, Tareq W. Haddad and Walden H. Lee. Most observations concern materials; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
2 of 2 observations on this 483 concern materials.
Most cited: 21 CFR 211.84 (1×) · 211.80 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Component testing is deficient in that each component is not tested for conformity with all appropriate…
- 02
Written procedures are not followed for…
This inspection in context
Anney Lin
9 documents · 2023–2026
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) 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 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jubilant HollisterStier LLC?
FDA listed 2 observations on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected Jubilant HollisterStier LLC?
Anney Lin, Bryan L. McGuckin, Cecilia H. Kieu, Homero W. Aguilar, Katherine E. Jacobitz, Katie L. Penno, Tareq W. Haddad and Walden H. Lee are named on this Form 483, for the inspection of Jun 8 – Jun 17, 2026. Each investigator has a profile showing what they cite most.
When was Jubilant HollisterStier LLC inspected by FDA?
The inspection ran Jun 8 – Jun 17, 2026, and the Form 483 is dated June 17, 2026.
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.