Jubilant HollisterStier LLC
Form 483 issued July 26, 2019 · Spokane, Washington
- Inspection
- Jul 15 – Jul 26, 2019
- Investigators
- Joey V. Quitania· Kristin M. Abaonza· Xiomara Copeland
- Observations
- 1
- Pages
- 3
- FEI number
- 3010477
In short: On July 26, 2019, FDA issued a Form 483 with 1 observation to Jubilant HollisterStier LLC in Spokane, Washington (FEI 3010477) 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.
Most cited: 21 CFR 211.188 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Batch production and control records do not include complete information relating to the production and…
This inspection in context
Joey V. Quitania
23 documents · 2009–2026
Cites 211.113 (control of microbiological contamination) 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 211.188
See how FDA wrote the same problem up elsewhere.
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.