Jubilant HollisterStier LLC
Form 483 issued September 21, 2017 · Spokane, Washington
- Inspection
- Sep 6 – Sep 21, 2017
- Investigators
- Gloria J. Baca· Tracy K. Li· Uttaniti Limchumroon
- Observations
- 3
- Pages
- 3
- FEI number
- 3010477
In short: On September 21, 2017, FDA issued a Form 483 with 3 observations to Jubilant HollisterStier LLC in Spokane, Washington (FEI 3010477) after an inspection that ran Sep 6 – Sep 21, 2017. The investigators were Gloria J. Baca, Tracy K. Li and Uttaniti Limchumroon. Most observations concern production and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern production.
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…
- 02
Written production and process control procedures are not followed in the execution of production…
- 03
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Gloria J. Baca
5 documents · 2016–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Washington.
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 3 observations on this Form 483, mostly about production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Jubilant HollisterStier LLC?
Gloria J. Baca, Tracy K. Li and Uttaniti Limchumroon are named on this Form 483, for the inspection of Sep 6 – Sep 21, 2017. Each investigator has a profile showing what they cite most.
When was Jubilant HollisterStier LLC inspected by FDA?
The inspection ran Sep 6 – Sep 21, 2017, and the Form 483 is dated September 21, 2017.
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.