Juno Therapeutics, Inc.
Form 483 issued October 16, 2020 · Bothell, Washington
- Inspection
- Oct 7 – Oct 16, 2020
- Investigators
- Eileen A. Liu· Prabhu P. Raju
- Observations
- 6
- Pages
- 8
- FEI number
- 3011834594
In short: On October 16, 2020, FDA issued a Form 483 with 6 observations to Juno Therapeutics, Inc. in Bothell, Washington (FEI 3011834594) after an inspection that ran Oct 7 – Oct 16, 2020. The investigators were Eileen A. Liu and Prabhu P. Raju. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 4 of 6 observations.
Most cited: 21 CFR 211.192 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch…
- 02
Written records of investigations into unexplained discrepancies, the failure of a batch or any of its…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Eileen A. Liu
41 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmJuno Therapeutics, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Juno Therapeutics, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, production and laboratory controls. 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 Juno Therapeutics, Inc.?
Eileen A. Liu and Prabhu P. Raju are named on this Form 483, for the inspection of Oct 7 – Oct 16, 2020. Each investigator has a profile showing what they cite most.
When was Juno Therapeutics, Inc. inspected by FDA?
The inspection ran Oct 7 – Oct 16, 2020, and the Form 483 is dated October 16, 2020.
How do I get the full Form 483 for Juno Therapeutics, Inc.?
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.