Jubilant HollisterStier LLC
Form 483 issued September 30, 2016 · Spokane, Washington
- Inspection
- Sep 19 – Sep 30, 2016
- Investigators
- Gloria J. Baca· Lynda L. Perry· Marijo B. Kambere
- Observations
- 3
- Pages
- 2
- FEI number
- 3010477
In short: On September 30, 2016, FDA issued a Form 483 with 3 observations to Jubilant HollisterStier LLC in Spokane, Washington (FEI 3010477) after an inspection that ran Sep 19 – Sep 30, 2016. The investigators were Gloria J. Baca, Lynda L. Perry and Marijo B. Kambere. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (2×) · 211.180 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The procedures for the annual quality standards record evaluation are deficient in that they do not…
- 02
Written production and process control procedures are not followed in the execution of production…
- 03
Written procedures are not drafted, reviewed and approved by…
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 211.100
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 quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Jubilant HollisterStier LLC?
Gloria J. Baca, Lynda L. Perry and Marijo B. Kambere are named on this Form 483, for the inspection of Sep 19 – Sep 30, 2016. Each investigator has a profile showing what they cite most.
When was Jubilant HollisterStier LLC inspected by FDA?
The inspection ran Sep 19 – Sep 30, 2016, and the Form 483 is dated September 30, 2016.
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.