Jubilant HollisterStier General Partnership
Form 483 issued June 1, 2018 · Kirkland, Canada
- Inspection
- May 24 – Jun 1, 2018
- Investigator
- Brett R. Havranek
- Observations
- 2
- Pages
- 3
- FEI number
- 3001623073
In short: On June 1, 2018, FDA issued a Form 483 with 2 observations to Jubilant HollisterStier General Partnership in Kirkland, Quebec (FEI 3001623073) after an inspection that ran May 24 – Jun 1, 2018. The investigator was Brett R. Havranek. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.113(b) (1×) · 211.170(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
This inspection in context
Brett R. Havranek
6 documents · 2015–2018
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Kansas.
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 211.113(b)
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 laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Jubilant HollisterStier General Partnership?
Brett R. Havranek is named on this Form 483, for the inspection of May 24 – Jun 1, 2018. Each investigator has a profile showing what they cite most.
When was Jubilant HollisterStier General Partnership inspected by FDA?
The inspection ran May 24 – Jun 1, 2018, and the Form 483 is dated June 1, 2018.
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.