Jubilant HollisterStier LLC
Form 483 issued April 15, 2014 · Spokane, Washington
- Inspection
- Mar 26 – Apr 15, 2014
- Investigators
- Andrew J. Idzior· Barbara J. Breithaupt· Eileen A. Liu
- Observations
- 18
- Pages
- 22
- FEI number
- 3010477
In short: On April 15, 2014, FDA issued a Form 483 with 18 observations to Jubilant HollisterStier LLC in Spokane, Washington (FEI 3010477) after an inspection that ran Mar 26 – Apr 15, 2014. The investigators were Andrew J. Idzior, Barbara J. Breithaupt, Eileen A. Liu, Mark W. Babbitt and Omotunde O. Osunsanmi. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Test procedures relative to appropriate laboratory testing for sterility and pyrogens are…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Laboratory records are deficient in that they do not include a complete record of all…
This inspection in context
Andrew J. Idzior
6 documents · 2013–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.167(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jubilant HollisterStier LLC?
FDA listed 18 observations on this Form 483, mostly about laboratory controls, production and quality system. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Jubilant HollisterStier LLC?
Andrew J. Idzior, Barbara J. Breithaupt, Eileen A. Liu, Mark W. Babbitt and Omotunde O. Osunsanmi are named on this Form 483, for the inspection of Mar 26 – Apr 15, 2014. Each investigator has a profile showing what they cite most.
When was Jubilant HollisterStier LLC inspected by FDA?
The inspection ran Mar 26 – Apr 15, 2014, and the Form 483 is dated April 15, 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.