Jubilant HollisterStier LLC

Form 483 issued June 17, 2026 · Spokane, Washington

Inspection
Jun 8 – Jun 17, 2026
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.

Materials2

Most cited: 21 CFR 211.84 (1×) · 211.80 (1×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01

    Component testing is deficient in that each component is not tested for conformity with all appropriate…

  2. 02

    Written procedures are not followed for…

The full 483

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This inspection in context

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?

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