Jubilant HollisterStier General Partnership
Form 483 issued February 28, 2023 · Kirkland, Canada
- Inspection
- Feb 20 – Feb 28, 2023
- Investigators
- Logan T. Williams· Rafeeq Habeeb
- Observations
- 4
- Pages
- 4
- FEI number
- 3001623073
In short: On February 28, 2023, FDA issued a Form 483 with 4 observations to Jubilant HollisterStier General Partnership in Kirkland, Canada (FEI 3001623073) after an inspection that ran Feb 20 – Feb 28, 2023. The investigators were Logan T. Williams and Rafeeq Habeeb. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
3 of 4 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The statistical quality control criteria fail to include appropriate acceptance…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Laboratory records do not include the initials or signature of a second person showing that the…
- 04
Laboratory records are deficient in that they do not include a statement of the results of…
This inspection in context
Logan T. Williams
32 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kentucky.
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 211.165(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jubilant HollisterStier General Partnership?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and production. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Jubilant HollisterStier General Partnership?
Logan T. Williams and Rafeeq Habeeb are named on this Form 483, for the inspection of Feb 20 – Feb 28, 2023. Each investigator has a profile showing what they cite most.
When was Jubilant HollisterStier General Partnership inspected by FDA?
The inspection ran Feb 20 – Feb 28, 2023, and the Form 483 is dated February 28, 2023.
How do I get the full Form 483 for Jubilant HollisterStier General Partnership?
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