Jubilant HollisterStier General Partnership

Form 483 issued June 14, 2024 · Kirkland, Canada

Inspection: Jun 3 – Jun 14, 2024
Investigator: Philip F. Istafanos
Observations: 15
Pages: 19
FEI number: 3001623073

In short: On June 14, 2024, FDA issued a Form 483 with 15 observations to Jubilant HollisterStier General Partnership in Kirkland, Quebec (FEI 3001623073) after an inspection that ran Jun 3 – Jun 14, 2024. The investigator was Philip F. Istafanos. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Laboratory controls and facilities & equipment account for 9 of 15 observations.

Laboratory controls5

Facilities & equipment4

Quality system2

Production2

Other2

Most cited: 21 CFR 211.42 (3×) · 211.160 (2×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

01
21 CFR 211.165
The statistical quality control criteria fail to include appropriate acceptance levels and rejection levels. Your firm…
02
21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch…
03
21 CFR 211.42
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
04
21 CFR 211.113
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…

11 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

Philip F. Istafanos

13 documents · 2014–2025

Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Canada.

The firm

Jubilant HollisterStier General Partnership history

All 7 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.42

See how FDA wrote the same problem up elsewhere.

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Form 483 from this inspectionMar 6, 2014$99

Jubilant HollisterStier General Partnership site file

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Questions about this 483

What did FDA find at Jubilant HollisterStier General Partnership?

FDA listed 15 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.

Who inspected Jubilant HollisterStier General Partnership?

Philip F. Istafanos is named on this Form 483, for the inspection of Jun 3 – Jun 14, 2024. Each investigator has a profile showing what they cite most.

When was Jubilant HollisterStier General Partnership inspected by FDA?

The inspection ran Jun 3 – Jun 14, 2024, and the Form 483 is dated June 14, 2024.

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.