Jubilant HollisterStier, LLC

Form 483 issued July 26, 2019 · Spokane, Washington

Inspection
Jul 15 – Jul 26, 2019
Observations
1
Pages
3

In short: On July 26, 2019, FDA issued a Form 483 with 1 observation to Jubilant HollisterStier, LLC in Spokane, Washington after an inspection that ran Jul 15 – Jul 26, 2019. The investigators were Joey V. Quitania, Kristin M. Abaonza and Xiomara Copeland. Most observations concern production; the most-cited regulation is 21 CFR 211.188 (batch production and control records).

At a glance

1 of 1 observations on this 483 concern production.

Production1

Most cited: 21 CFR 211.188 (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

    Batch production and control records do not include complete information relating to the production and…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

Questions about this 483

What did FDA find at Jubilant HollisterStier, LLC?

FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.

Who inspected Jubilant HollisterStier, LLC?

Joey V. Quitania, Kristin M. Abaonza and Xiomara Copeland are named on this Form 483, for the inspection of Jul 15 – Jul 26, 2019. Each investigator has a profile showing what they cite most.

When was Jubilant HollisterStier, LLC inspected by FDA?

The inspection ran Jul 15 – Jul 26, 2019, and the Form 483 is dated July 26, 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.

$99Get it free