Jubilant HollisterStier LLC
Form 483 issued August 31, 2021 · Spokane, Washington
- Inspection
- Aug 24 – Aug 31, 2021
- Investigators
- Jacqueline Diaz-Albertini· Laurel A. Beer
- Observations
- 3
- Pages
- 3
- FEI number
- 3010477
In short: On August 31, 2021, FDA issued a Form 483 with 3 observations to Jubilant HollisterStier LLC in Spokane, Washington (FEI 3010477) after an inspection that ran Aug 24 – Aug 31, 2021. The investigators were Jacqueline Diaz-Albertini and Laurel A. Beer. Most observations concern production and quality system.
At a glance
Production and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which monitor the output of those manufacturing processes that may be…
- 02
Complaint investigations involving Precipitate in product are not complete in that there is no assessment made…
- 03
Stability testing methods have not been evaluated to assure they are aligned with…
This inspection in context
Jacqueline Diaz-Albertini
7 documents · 1996–2021
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New York.
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 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jubilant HollisterStier LLC?
FDA listed 3 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Jubilant HollisterStier LLC?
Jacqueline Diaz-Albertini and Laurel A. Beer are named on this Form 483, for the inspection of Aug 24 – Aug 31, 2021. Each investigator has a profile showing what they cite most.
When was Jubilant HollisterStier LLC inspected by FDA?
The inspection ran Aug 24 – Aug 31, 2021, and the Form 483 is dated August 31, 2021.
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.