Jubilant HollisterStier General Partnership
Form 483 issued March 6, 2014 · Kirkland, Canada
- Inspection
- Jun 3 – Jun 14, 2024
- Investigators
- Crystal Monroy· Jose E. Melendez· Philip F. Istafanos
- Observations
- 14
- Pages
- 19
- FEI number
- 3001623073
In short: On March 6, 2014, FDA issued a Form 483 with 14 observations to Jubilant HollisterStier General Partnership in Kirkland, Canada (FEI 3001623073) after an inspection that ran Jun 3 – Jun 14, 2024. The investigators were Crystal Monroy, Jose E. Melendez and 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 14 observations.
Most cited: 21 CFR 211.42 (2×) · 211.167 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch…
- 03
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Crystal Monroy
15 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jubilant HollisterStier General Partnership?
FDA listed 14 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?
Crystal Monroy, Jose E. Melendez and Philip F. Istafanos are 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 March 6, 2014.
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.