Jubilant HollisterStier LLC
Form 483 issued December 2, 2014 · Spokane, Washington
- Inspection
- Nov 3 – Dec 2, 2014
- Investigators
- Debra M. Emerson· Eileen A. Liu· Heika R. Tait
- Observations
- 4
- Pages
- 6
- FEI number
- 3010477
In short: On December 2, 2014, FDA issued a Form 483 with 4 observations to Jubilant HollisterStier LLC in Spokane, Washington (FEI 3010477) after an inspection that ran Nov 3 – Dec 2, 2014. The investigators were Debra M. Emerson, Eileen A. Liu, Heika R. Tait, Mihaly S. Ligmond and Rebeca Rodriguez. Most observations concern production and quality system.
At a glance
Production and quality system account for 4 of 4 observations.
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 prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Written records of investigations into unexplained discrepancies do not always include…
- 03
Procedures describing the handling of all written and oral complaints regarding a drug…
- 04
Batch production and control records do not include complete information relating to the production and…
This inspection in context
Debra M. Emerson
27 documents · 2008–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jubilant HollisterStier LLC?
FDA listed 4 observations on this Form 483, mostly about production and quality system. The opening words of each observation are shown on this page.
Who inspected Jubilant HollisterStier LLC?
Debra M. Emerson, Eileen A. Liu, Heika R. Tait, Mihaly S. Ligmond and Rebeca Rodriguez are named on this Form 483, for the inspection of Nov 3 – Dec 2, 2014. Each investigator has a profile showing what they cite most.
When was Jubilant HollisterStier LLC inspected by FDA?
The inspection ran Nov 3 – Dec 2, 2014, and the Form 483 is dated December 2, 2014.
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.