Jubilant HollisterStier LLC
Form 483 issued December 15, 2010 · Spokane, Washington
- Inspection
- Dec 6 – Dec 15, 2010
- Investigator
- Alexander M. Kaylnvestigator
- Observations
- 10
- Pages
- 4
- FEI number
- 3010477
In short: On December 15, 2010, FDA issued a Form 483 with 10 observations to Jubilant HollisterStier LLC in Spokane, Washington (FEI 3010477) after an inspection that ran Dec 6 – Dec 15, 2010. The investigator was Alexander M. Kaylnvestigator. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 6 of 10 observations.
Most cited: 21 CFR 211.188 (2×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm has failed to adequately account for final fill drug and biologic product vials filled…
- 02
There is a lack of accountability between the number of (b) (4) Sterile Diluent, and various…
- 03
SOP 101.62, Pre-Start Check List for Aseptic and Controlled Areas is used to record activities prior…
- 04
SOP 102.34, Annual Product Review (APR), dated 29 November 2010, defines the APR completion due dates…
This inspection in context
Alexander M. Kaylnvestigator
1 document · 2010
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in Washington.
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 211.188
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 quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Jubilant HollisterStier LLC?
Alexander M. Kaylnvestigator is named on this Form 483, for the inspection of Dec 6 – Dec 15, 2010. Each investigator has a profile showing what they cite most.
When was Jubilant HollisterStier LLC inspected by FDA?
The inspection ran Dec 6 – Dec 15, 2010, and the Form 483 is dated December 15, 2010.
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.