Jubilant HollisterStier LLC
Form 483 issued July 31, 2015 · Spokane, Washington
- Inspection
- Jul 27 – Jul 31, 2015
- Investigators
- Ashar P. Parikh· Don H. Bark· Gerard P. De Leon
- Observations
- 1
- Pages
- 2
- FEI number
- 3010477
In short: On July 31, 2015, FDA issued a Form 483 with 1 observation to Jubilant HollisterStier LLC in Spokane, Washington (FEI 3010477) after an inspection that ran Jul 27 – Jul 31, 2015. The investigators were Ashar P. Parikh, Don H. Bark, Gerard P. De Leon, Lynda L. Perry and Marijo B. Kambere. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Ashar P. Parikh
19 documents · 2014–2026
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 211.192
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 quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Jubilant HollisterStier LLC?
Ashar P. Parikh, Don H. Bark, Gerard P. De Leon, Lynda L. Perry and Marijo B. Kambere are named on this Form 483, for the inspection of Jul 27 – Jul 31, 2015. Each investigator has a profile showing what they cite most.
When was Jubilant HollisterStier LLC inspected by FDA?
The inspection ran Jul 27 – Jul 31, 2015, and the Form 483 is dated July 31, 2015.
How do I get the full Form 483 for Jubilant HollisterStier LLC?
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