Jubilant HollisterStier General Partnership
Form 483 issued December 10, 2015 · Kirkland, Canada
- Inspection
- Nov 30 – Dec 10, 2015
- Investigator
- Claire M. Minden
- Observations
- 2
- Pages
- 2
- FEI number
- 3001623073
In short: On December 10, 2015, FDA issued a Form 483 with 2 observations to Jubilant HollisterStier General Partnership in Kirkland, Canada (FEI 3001623073) after an inspection that ran Nov 30 – Dec 10, 2015. The investigator was Claire M. Minden. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.100 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviations from written production and process control…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
This inspection in context
Claire M. Minden
26 documents · 2013–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Louisiana.
The firmJubilant HollisterStier General Partnership history
All 7 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 General Partnership?
FDA listed 2 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 General Partnership?
Claire M. Minden is named on this Form 483, for the inspection of Nov 30 – Dec 10, 2015. Each investigator has a profile showing what they cite most.
When was Jubilant HollisterStier General Partnership inspected by FDA?
The inspection ran Nov 30 – Dec 10, 2015, and the Form 483 is dated December 10, 2015.
How do I get the full Form 483 for Jubilant HollisterStier General Partnership?
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.