Jubilant HollisterStier LLC
Form 483 issued October 26, 2018 · Spokane, Washington
- Inspection
- Oct 16 – Oct 26, 2018
- Investigator
- Mihaly S. Ligmond
- Observations
- 10
- Pages
- 4
- FEI number
- 3010477
In short: On October 26, 2018, FDA issued a Form 483 with 10 observations to Jubilant HollisterStier LLC in Spokane, Washington (FEI 3010477) after an inspection that ran Oct 16 – Oct 26, 2018. The investigator was Mihaly S. Ligmond. Most observations concern production and packaging & labeling.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to assure that correct labels are used for drug…
- 02
Control procedures are not established which monitor the output of those manufacturing processes that may be…
- 03
The batch production and control records are deficient in that they do not include identification of…
- 04
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
This inspection in context
Mihaly S. Ligmond
20 documents · 2006–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ireland.
The firmJubilant HollisterStier LLC history
All 13 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.130
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jubilant HollisterStier LLC?
FDA listed 10 observations on this Form 483, mostly about production, packaging & labeling and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Jubilant HollisterStier LLC?
Mihaly S. Ligmond is named on this Form 483, for the inspection of Oct 16 – Oct 26, 2018. Each investigator has a profile showing what they cite most.
When was Jubilant HollisterStier LLC inspected by FDA?
The inspection ran Oct 16 – Oct 26, 2018, and the Form 483 is dated October 26, 2018.
How do I get the full Form 483 for Jubilant HollisterStier LLC?
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.